UCB Media Room: American Academy of Neurology (AAN) Annual Meeting

https://mb.cision.com/Public/18595/3537505/8e90d5ae61cc51dc_800x800ar.png ** UCB Showcases Strength of Broad Neurology Portfolio at 74th American Aca= demy of Neurology (AAN) Annual Meeting ------------------------------------------------------------ =C2=B7 Scientific presentations illustrate UCB=E2=80=99s commitment to addr= essing unmet needs of people living with a broad range of serious neurologi= cal diseases=C2=A0 =C2=B7 New data focused on epilepsy and Parkinson=E2=80=99s disease (PD), i= ncluding real-world use of BRIVIACT^=C2=AE (brivaracetam) CV, long-term use= of FINTEPLA^=C2=AE =E2=96=BC =C2=A0 (fenfluramine) CIV [Lennox Gastaut syndrome indication in the US onl= y] early use of NAYZILAM^=C2=AE (midazolam) CIV [FDA approved only] and pre= -clinical evaluation of an investigational treatment for Parkinson=E2=80=99= s disease (UCB0599) =C2=B7 UCB will also host an industry sponsored therapeutic update session = =E2=80=98MG: What lies beneath?=E2=80=99 on April 4 to contribute to improv= ed understanding about Myasthenia Gravis=C2=A0 Brussels (Belgium), 1 April 2022 =E2=80=93 07:00 (CET) =E2=80=93 UCB today = announced that new data from its expansive and innovative neurology portfol= io will be presented at the 74th American Academy of Neurology (AAN) Annual= Meeting, from 2-7 April 2022.=C2=A0 Twelve scientific abstracts have been accepted including data from UCB=E2= =80=99s epilepsy portfolio and Parkinson=E2=80=99s disease development prog= ram.=C2=A0 =E2=80=9CAt UCB, we are inspired to develop new solutions that help transfo= rm the lives of people living with severe neurological disorders. Our world= -class scientists make this ambition possible; advancing our understanding = of human biology and driving breakthroughs in areas of science,=E2=80=9D sa= id Charl van Zyl, Executive Vice President Neurology & Head of Europe/Inter= national Markets at UCB. =E2=80=9CWe are excited to showcase the scale and = passion of our commitment at AAN, building on our legacy and expertise in e= pilepsy, myasthenia gravis and Parkinson=E2=80=99s disease.=E2=80=9D Epilepsy At the congress, UCB will be reporting data from several significant clinic= al epilepsy studies from its broad epilepsy portfolio. Notably, these data = include real-world retrospective interim evidence evaluating the effectiven= ess and tolerability of brivaracetam*, for adult patients with partial-onse= t seizures, in routine clinical practice in a large multicenter internation= al patient population, as well as prospective US RWE data. In the U.S., bri= varacetam* is approved for the treatment of partial onset seizures in patie= nts 1 month of age and older.^2 =C2=A0 Additionally, presented data will evaluate dose-response relationships for = the impact of fenfluramine* on everyday executive function in patients, as = captured using the Behavior Rating Inventory of Executive Function (BRIEF^= =C2=AE). In the US, fenfluramine is indicated for the treatment of seizures= associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in = patients 2 years of age and older.^1=C2=A0 Data will also summarize the early use of midazolam nasal spray in patients= with seizure clusters. In the U.S., midazolam nasal spray=C2=A0is indicate= d for the acute treatment of intermittent, stereotypic episodes of frequent= seizure activity (i.e., seizure clusters, acute repetitive seizures) that = are distinct from a patient=E2=80=99s usual seizure pattern in patients wit= h epilepsy 12 years of age and older.^5 Please see IMPORTANT SAFETY INFORMA= TION, including Boxed Warning, below.^1 Two podium presentations will also be taking place during the congress, hig= hlighting the long-term evidence of the cardiovascular safety profile of fe= nfluramine. Please note that fenfluramine is available only through the REM= S Program due to the risk of valvular heart disease and pulmonary arterial = hypertension. Please see IMPORTANT SAFETY INFORMATION, including Boxed Warn= ing, below.^1=C2=A0 =C2=B7 Interim Analysis of Long-Term Safety and Efficacy of FINTEPLA=C2=AE = (fenfluramine) in Patients with Lennox-Gastaut Syndrome Knupp K, Scheffer I= , Ceulemans B, et al.=C2=A0Session S13: Epilepsy/Clinical Neurophysiology (= EEG): Antiseizure Medications.=C2=A0Authors available: Monday, April 4 2022= , at 2:48 PM PT =C2=B7 Long-Term Cardiovascular Safety of Fenfluramine for Lennox-Gastaut S= yndrome: Interim Analysis of Open-Label Safety Study Agarwal A, Farfel G, G= ammaitoni A, et al.=C2=A0Session S24: Epilepsy/Clinical Neurophysiology (EE= G): Clinical Epilepsy.=C2=A0Authors available: Tuesday, April 5 2022, at 4:= 18 PM PT An additional presentation will take place to summarize a real-world study = of brivaracetam in the United States. =C2=B7 Real-world Study of Brivaracetam in the United States. Dave H, Frenc= h JA, Altalib HH, Henninger H, Porter RJ, Gelfand M, Martin MS, Dongre P, E= lmoufti S, Schulz AL, Sperling MR.=C2=A0Session S13 Epilepsy/clinical Neuro= physiology (EEG) antiseizure medications.=C2=A0Authors available: Monday, A= pril 4 at 1:00 PM PT *Licenses may vary by country. Please always refer to the Prescribing Infor= mation available in your country Myasthenia Gravis UCB will be hosting an Industry Therapeutic Update titled =E2=80=98MG: What= lies beneath? The MG pathophysiology forum=E2=80=99, Monday, 4 April, 19:0= 0-20:15 PT (Leonesa Ballroom III, Grand Hyatt Seattle). An esteemed faculty= will explore how advances in understanding of the pathogenic mechanisms of= generalized myasthenia gravis are a catalyst for innovation in disease man= agement. UCB is excited to be progressing knowledge, understanding and disc= ussion about disease management and the potential benefits of targeted ther= apies in this rare neuro-muscular disease, and is very proud to be part of = the rapidly evolving MG community alongside patients, clinicians, caregiver= s and healthcare providers. Parkinson=E2=80=99s disease In Parkinson=E2=80=99s disease, UCB=E2=80=99s long-term ambition is to tran= sform the treatment landscape from the management of symptoms, to treatment= s that can slow or stop the progression of disease. At AAN UCB has a podium= presentation on the data evaluating the preclinical effects of chronic dos= ing of its investigational molecule currently in development with Novartis,= (UCB0599), in =CE=B1-synuclein transgenic mice. An additional study review= ed the extent to which legacy patient-reported outcome instruments are fit = for purpose for use in trials involving people with early-stage Parkinson= =E2=80=99s disease. =C2=B7 Preclinical In Vivo Characterization of UCB0599, an Orally Available= , Small Molecule Inhibitor of a-Synuclein Misfolding in Development for Par= kinson's Disease. Price D, Khan A, Angers R, Cardenas A, Key-Prato M, Citro= n M, Bonhaus D, Biere A.=C2=A0S36/ Movement Disorders: clinical and patholo= gic characterization of neurodegenerative movement disorders Poster presentations The following is a guide to the UCB-sponsored poster presentations at the 7= 4th American Academy of Neurology Annual Meeting:=C2=A0 Brivaracetam =C2=B7 12-month effectiveness and tolerability of brivaracetam in the real-= world: interim analysis of the international, non-interventional EXPERIENCE= study. Villanueva V, D=E2=80=99Souza W, Faught E, Klein P, Reuber M, Rosen= ow F, Salas-Puig J, Strzelczyk A, Szaflarski J, Ricchetti-Masterson K, Lalo= yaux C, Sendersky V, Zhou S, Floricel F, Daniels T, Steinhoff B =C2=B7 Effectiveness and Tolerability of Brivaracetam by Reason for Initiat= ion in Adults with Focal Seizures: Post-hoc Analysis of a Real-world, US St= udy. Henninger H, Sperling MR, Altalib HH, Dave H, Gelfand M, Porter RJ, Ma= rtin MS, Elmoufti S, Schulz AL, Dongre P, French JA =C2=B7 Patient-reported Outcomes in Mood, Fatigue, Sleep Disturbance, and D= isability While on Brivaracetam Treatment: a Prospective Observational Stud= y. Altalib HH, French JA, Sperling MR, Henninger H, Dave H, Gelfand M, Schu= lz AL, Elmoufti S, Dongre P, Martin MS =C2=B7 Time-course of Treatment-emergent Adverse Events Potentially Associa= ted with Behavioral Disorders during Adjunctive Brivaracetam Treatment of A= dults with Focal Seizures. Meador KJ, Dimova S, Laloyaux C, Nondonfaz X, Fl= oricel F, Elmoufti S, Klein P =C2=B7 Cognitive and Behavioral Effects and Tolerability of Adjunctive Briv= aracetam in Children and Adolescents with Focal Seizures: Pooled Interim An= alysis. Elshoff JP, Fleyshman S, De La Loge C, Nondonfaz X, Reichel C, Flor= icel F, Smeyers P Fenfluramine oral solution [Lennox Gastaut syndrome indication in the US on= ly] Fenfluramine Improves Everyday Executive Functioning in Patients With Lenno= x-Gastaut Syndrome: Analysis of Phase 3 Data Bishop K, Isquith P, Giola G, Knupp K, Sullivan J, Nabbout R, Farfel G, Gal= er B, Gammaitoni A Midazolam nasal spray [FDA approved only] =C2=B7 Early Intervention With Midazolam Nasal Spray and Efficacy in Patien= ts With Seizure Clusters: Post-hoc Analysis of an Open-label Extension Tria= l. Wheless JW, Brunnert M, Floricel F, Dimova S, Fannon B Parkinson=E2=80=99s disease =C2=B7 Outcome assessment in early-stage Parkinson=E2=80=99s disease (PD) c= linical trials: Are legacy patient-reported outcome (PRO) instruments =E2= =80=98fit for purpose=E2=80=99? Morel T, Cleanthous S, Andrejack J, Barker = RA, Blavat G, Boroojerdi B, Brooks W, Burns P, Cano S, Gallagher C, Gosden = L, Siu C, Slagle AF, Trenam K, Ratcliffe N, Schroeder K About BRIVIACT^=C2=AE (brivaracetam) About BRIVIACT=C2=AE (brivaracetam) CV in the U.S.^2 =C2=B7 BRIVIACT was approved in the U.S. in 2016 as an add-on therapy for a= dult patients with partial-onset seizures. BRIVIACT was approved as monothe= rapy for adults in September 2017, and as monotherapy or adjunctive therapy= in patients four years of age and older with partial-onset seizures in 201= 8. In August 2021, BRIVIACT was approved for the treatment of partial-onset= seizures in patients as young as one month of age. BRIVIACT is available i= n three formulations: oral tablets, oral solution, and intravenous (IV) inj= ection. More information is available at Drugs@FDA: FDA-Approved Drugs (htt= ps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=3Doverview.pro= cess&ApplNo=3D205836) . BRIVIACT IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS =C2=B7 Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVI= ACT, increase the risk of suicidal behavior and ideation. Monitor patients = taking BRIVIACT for the emergence or worsening of depression; unusual chang= es in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advis= e patients, their caregivers, and/or families to be alert for these behavio= ral changes and report them immediately to a healthcare provider. =C2=B7 Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue,= dizziness, and disturbance in coordination. Monitor patients for these sig= ns and symptoms and advise them not to drive or operate machinery until the= y have gained sufficient experience on BRIVIACT. =C2=B7 Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse r= eactions, including non-psychotic and psychotic symptoms in adult and pedia= tric patients. Advise patients to report these symptoms immediately to a he= althcare provider. =C2=B7 Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bro= nchospasm and angioedema have been reported. Discontinue BRIVIACT if a pati= ent develops a hypersensitivity reaction after treatment. BRIVIACT is contr= aindicated in patients with a prior hypersensitivity reaction to brivaracet= am or any of the inactive ingredients. =C2=B7 Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, = BRIVIACT should generally be withdrawn gradually because of the risk of inc= reased seizure frequency and status epilepticus. ADVERSE REACTIONS In adult adjunctive therapy placebo-controlled clinical trials, the most co= mmon adverse reactions (at least 5% for BRIVIACT and at least 2% more frequ= ently than placebo) were somnolence and sedation, dizziness, fatigue, and n= ausea and vomiting symptoms. Adverse reactions reported in clinical studies= of pediatric patients were generally similar to those in adult patients. A= dverse reactions with BRIVIACT injection in adult and pediatric patients we= re generally similar to those observed with BRIVIACT tablets. =C2=A0Other a= dverse events that occurred in adult patients who received BRIVIACT injecti= on included dysgeusia, euphoric mood, feeling drunk, and infusion site pain= .=C2=A0 BRIVIACT is a Schedule V controlled substance. Please refer to the full US Prescribing Information (https://www.ucb-usa.co= m/briviact-prescribing-information.pdf) and visit www.BRIVIACThcp.com. Important Safety Information about BRIVIACT^=C2=AE in the EU and EEA^3 BRIVIACT^=C2=AE (brivaracetam) is indicated as adjunctive therapy in the tr= eatment of partial-onset seizures with or without secondary generalisation = in adults, adolescents and children from 2 years of age with epilepsy. Cont= raindications Hypersensitivity to the active substance, other pyrrolidone d= erivatives or any of the excipients. Special warnings and precautions for u= se Suicidal ideation and behaviour have been reported in patients treated w= ith anti-epileptic drugs (AEDs) in several indications, including BRIVIACT^= =C2=AE. =C2=A0Patients should be monitored for signs of suicidal ideation a= nd behaviour and appropriate treatment should be considered. Patients (and = caregivers) should be advised to seek medical advice should any signs of su= icidal ideation or behaviour emerge. BRIVIACT=C2=AE film-coated tablets con= tain lactose. Patients with rare hereditary problems of galactose intoleran= ce, total lactase deficiency or glucose-galactose malabsorption should not = take BRIVIACT^=C2=AE. Brivaracetam film-coated tablets, solution for inject= ion/infusion and oral solution contain less than 1 mmol sodium (23mg) per t= ablet/vial/ml respectively, that is to say essentially =E2=80=98sodium free= =E2=80=99. The oral solution contains 168 mg sorbitol (E420) in each ml. Pa= tients with hereditary fructose intolerance (HFI) should not take this medi= cinal product. The oral solution contains methyl parahydroxybenzoate (E218)= , which may cause allergic reactions (possibly delayed). Brivaracetam oral = solution contains propylene glycol (E1520). Posology No dose adjustment is = needed in adults with impaired renal function. Based on data in adults, no = dose adjustment is necessary neither in paediatric patients with impaired r= enal function. No clinical data are available in paediatric patients with r= enal impairment. In patients with hepatic impairment, the following adjuste= d doses, administered in 2 divided doses, approximately 12 hours apart, are= recommended for all stages of hepatic impairment: In adults, adolescents a= nd children weighing =E2=89=A550 kg, a 50 mg/day starting dose is recommend= ed, with a maximum daily dose of 150 mg/day. For adolescents and children w= eighing from 20 kg to <50 kg, a 1 mg/kg/day starting dose is recommended, w= ith a maximum daily dose of 3 mg/kg/day. For children weighing from 10 kg t= o <20 kg, a 1 mg/kg/day starting dose is recommended, with a maximum daily = dose of 4 mg/kg/day. No clinical data are available in paediatric patients = with hepatic impairment. Interaction with other medicinal products and other forms of interaction. W= ith co-administration of BRIVIACT=C2=AE 200 mg single dose and ethanol 0.6 = g/L continuous infusion in healthy subjects there was no pharmacokinetic in= teraction, but the effect of alcohol on psychomotor function, attention and= memory was doubled. Intake of BRIVIACT=C2=AE with alcohol is not recommend= ed. Limited clinical data are available implying that coadministration of c= annabidiol may increase the plasma exposure of brivaracetam, possibly throu= gh CYP2C19 inhibition, but the clinical relevance is uncertain. In healthy = subjects, co-administration with rifampicin, a strong enzyme-inducer (600 m= g/day for 5 days), decreased BRIVIACT=C2=AE area under the plasma concentra= tion curve (AUC) by 45%. Prescribers should consider adjusting the dose of = BRIVIACT=C2=AE for patients starting or ending treatment with rifampicin. O= ther strong enzyme-inducers (such as St John=C2=B4s wort [Hypericum perfora= tum]) may also decrease the systemic exposure of BRIVIACT=C2=AE. Therefore,= starting or ending treatment with St John=E2=80=99s wort should be done wi= th caution. In vitro studies have shown that brivaracetam exhibits little o= r no inhibition of CYP450 isoforms except for CYP2C19. Brivaracetam may inc= rease plasma concentrations of medicinal products metabolised by CYP2C19 (e= .g., lansoprazole, omeprazole, diazepam). CYP2B6 induction has not been inv= estigated in vivo and BRIVIACT=C2=AE may decrease plasma concentrations of = medicinal products metabolised by CYP2B6 (e.g. efavirenz). In vitro studies= have also shown that BRIVIACT=C2=AE has inhibitory effects on OAT3. BRIVIA= CT=C2=AE 200 mg/day may increase plasma concentrations of medicinal product= s transported by OAT3. BRIVIACT=C2=AE plasma concentrations are decreased w= hen co-administered with strong enzyme inducing antiepileptic drugs (carbam= azepine, phenobarbital, phenytoin) but no dose adjustment is required. Effe= cts on ability to drive and use machines BRIVIACT=C2=AE, has minor or moder= ate influence on the ability to drive and use machines. Patients should be = advised not to drive a car or to operate other potentially hazardous machin= es until they are familiar with the effects of BRIVIACT=C2=AE, on their abi= lity to perform such activities. Undesirable effects. The most frequently r= eported adverse reactions with BRIVIACT=C2=AE (reported by >10% of patients= ) were somnolence (14.3%) and dizziness (11.0%). They were usually mild to = moderate in intensity. Somnolence and fatigue were reported at higher incid= ences with increasing dose. Very common adverse reactions (=E2=89=A51% to <= 10%) were influenza, decreased appetite, depression, anxiety, insomnia, irr= itability, convulsion, vertigo, upper respiratory tract infections, cough, = nausea, vomiting, constipation and fatigue. Neutropenia has been reported i= n 0.5% (6/1,099) BRIVIACT=C2=AE patients and 0% (0/459) placebo-treated pat= ients. Four of these patients had decreased neutrophil counts at baseline, = and experienced additional decrease in neutrophil counts after initiation o= f BRIVIACT=C2=AE. None of the six cases were severe, required any specific = treatment, led to BRIVIACT=C2=AE =C2=A0 discontinuation or had associated i= nfections. Suicidal ideation was reported in 0.3 % (3/1099) of BRIVIACT=C2= =AE treated patients and 0.7 % (3/459) of placebo-treated patients. In shor= t-term clinical studies of BRIVIACT=C2=AE in patients with epilepsy, there = were no cases of completed suicide and suicide attempt, however both were r= eported in the long-term open-label extension studies. Reactions suggestive= of immediate (Type I) hypersensitivity have been reported in a small numbe= r of BRIVIACT=C2=AE patients (9/3022) during clinical development. The safe= ty profile of brivaracetam observed in children from 1 month of age was con= sistent with the safety profile observed in adults. In the open label, unco= ntrolled, long-term studies suicidal ideation was reported in 4.7 % of paed= iatric patients assessed from 6 years onwards (more common in adolescents) = compared with 2.4 % of adults and behavioural disorders were reported in 24= .8 % of paediatric patients compared with 15.1 % of adults. The majority of= events were mild or moderate in intensity, were non-serious, and did not l= ead to discontinuation of study drug. An additional adverse reaction report= ed in children was psychomotor hyperactivity (4.7 %). No specific pattern o= f adverse event (AE) was identified in children from 1 month to < 4 years o= f age when compared to older paediatric age groups. No significant safety i= nformation was identified indicating the increasing incidence of a particul= ar AE in this age group. As data available in children younger than 2 years= of age are limited, brivaracetam is not indicated in this age range. No cl= inical data are available in neonates. Overdose There is limited clinical e= xperience with BRIVIACT=C2=AE overdose in humans. Somnolence and dizziness = were reported in a healthy subject taking a single dose of 1,400 mg of BRIV= IACT=C2=AE. The following adverse reactions were reported with brivaracetam= overdose: nausea, vertigo, balance disorder, anxiety, fatigue, irritabilit= y, aggression, insomnia, depression, and suicidal ideation in the post-mark= eting experience. In general, the adverse reactions associated with brivara= cetam overdose were consistent with the known adverse reactions. There is n= o specific antidote. Treatment of an overdose should include general suppor= tive measures. Since less than 10% of BRIVIACT=C2=AE is excreted in urine, = haemodialysis is not expected to significantly enhance BRIVIACT=C2=AE clear= ance. Refer to the European Summary of Product Characteristics for other adverse = reactions and full prescribing information. Date of revision: =C2=A024 Febr= uary 2022 http://www.ema.europa.eu/ About FINTEPLA^=C2=AE (fenfluramine)=C2=A0 Important Safety Information about FINTEPLA=C2=AE (fenfluramine) oral solut= ion, CIV in the US^1 INDICATIONS AND USAGE FINTEPLA is indicated for the treatment of seizures associated with Dravet = syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age = and older. IMPORTANT SAFETY INFORMATION BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION =C2=B7 There is an association between serotonergic drugs with 5-HT2B recep= tor agonist activity, including fenfluramine (the active ingredient in FINT= EPLA), and valvular heart disease and pulmonary arterial hypertension.=C2= =A0 =C2=B7 Echocardiogram assessments are required before, during, and after tr= eatment with FINTEPLA.=C2=A0 =C2=B7 FINTEPLA is available only through a restricted program called the F= INTEPLA REMS. CONTRAINDICATIONS FINTEPLA is contraindicated in patients with hypersensitivity to fenflurami= ne or any of the excipients in FINTEPLA and with concomitant use, or within= 14 days of the administration of monoamine oxidase inhibitors because of a= n increased risk of serotonin syndrome. WARNINGS AND PRECAUTIONS Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warni= ng): Because of the association between serotonergic drugs with 5 HT2B rece= ptor agonist activity, including fenfluramine (the active ingredient in FIN= TEPLA), and valvular heart disease (VHD) and pulmonary arterial hypertensio= n (PAH), cardiac monitoring via echocardiogram is required prior to startin= g treatment, during treatment, and after treatment with FINTEPLA concludes.= Cardiac monitoring via echocardiogram can aid in early detection of these = conditions. In clinical trials for DS and LGS of up to 3 years in duration,= no patient receiving FINTEPLA developed VHD or PAH. Monitoring: Prior to starting treatment, patients must undergo an echocardi= ogram to evaluate for VHD and PAH. Echocardiograms should be repeated every= 6 months, and once at 3-6 months post treatment with FINTEPLA. The prescriber must consider the benefits versus the risks of initiating or= continuing treatment with FINTEPLA if any of the following signs are obser= ved via echocardiogram: valvular abnormality or new abnormality; VHD indica= ted by mild or greater aortic regurgitation or moderate or greater mitral r= egurgitation, with additional characteristics of VHD (eg, valve thickening = or restrictive valve motion); PAH indicated by elevated right heart/pulmona= ry artery pressure (PASP >35mmHg). FINTEPLA REMS Program (see Boxed Warning): FINTEPLA is available only throu= gh a restricted distribution program called the FINTEPLA Risk Evaluation an= d Mitigation Strategy (REMS) Program. Prescribers must be certified by enro= lling in the FINTEPLA REMS. Prescribers must counsel patients receiving FIN= TEPLA about the risk of valvular heart disease and pulmonary arterial hyper= tension, how to recognize signs and symptoms of valvular heart disease and = pulmonary arterial hypertension, the need for baseline (pretreatment) and p= eriodic cardiac monitoring via echocardiogram during FINTEPLA treatment, an= d cardiac monitoring after FINTEPLA treatment. Patients must enroll in the = FINTEPLA REMS and comply with ongoing monitoring requirements. The pharmacy= must be certified by enrolling in the FINTEPLA REMS and must only dispense= to patients who are authorized to receive FINTEPLA. Wholesalers and distri= butors must only distribute to certified pharmacies. Further information is= available at www.FinteplaREMS.com or by telephone at 1-877-964-3649. Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in ap= petite and weight. Decreases in weight appear to be dose related. Approxima= tely half of the patients with LGS and most patients with DS resumed the ex= pected measured increases in weight during the open-label extension studies= . Weight should be monitored regularly during treatment with FINTEPLA, and = dose modifications should be considered if a decrease in weight is observed= .=C2=A0 Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation= , and lethargy. Other central nervous system (CNS) depressants, including a= lcohol, could potentiate these effects of FINTEPLA. Prescribers should moni= tor patients for somnolence and sedation and should advise patients not to = drive or operate machinery until they have gained sufficient experience on = FINTEPLA to gauge whether it adversely affects their ability to drive or op= erate machinery. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including FINTE= PLA, increase the risk of suicidal thoughts or behaviors in patients taking= these drugs for any indication. Patients treated with an AED for any indic= ation should be monitored for the emergence or worsening of depression, sui= cidal thoughts or behaviors, or any unusual changes in mood or behavior. Anyone considering prescribing FINTEPLA or any other AED must balance the r= isk of suicidal thoughts or behaviors with the risks of untreated illness. = Epilepsy and many other illnesses for which AEDs are prescribed are themsel= ves associated with morbidity and mortality and an increased risk of suicid= al thoughts and behaviors. Should suicidal thoughts and behaviors emerge du= ring treatment, consider whether the emergence of these symptoms in any giv= en patient may be related to the illness being treated. Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should gener= ally be withdrawn gradually because of the risk of increased seizure freque= ncy and status epilepticus. If withdrawal is needed because of a serious ad= verse reaction, rapid discontinuation can be considered. Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening cond= ition, may occur with FINTEPLA, particularly during concomitant administrat= ion of FINTEPLA with other serotonergic drugs, including, but not limited t= o, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selectiv= e serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), = bupropion, triptans, dietary supplements (eg, St. John=E2=80=99s Wort, tryp= tophan), drugs that impair metabolism of serotonin (including monoamine oxi= dase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextrome= thorphan, lithium, tramadol, and antipsychotics with serotonergic agonist a= ctivity. Patients should be monitored for the emergence of signs and sympto= ms of serotonin syndrome, which include mental status changes (eg, agitatio= n, hallucinations, coma), autonomic instability (eg, tachycardia, labile bl= ood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoor= dination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea= ). If serotonin syndrome is suspected, treatment with FINTEPLA should be st= opped immediately and symptomatic treatment should be started.=C2=A0 Increase in Blood Pressure: FINTEPLA can cause an increase in blood pressur= e. Rare cases of significant elevation in blood pressure, including hyperte= nsive crisis, has been reported in adult patients treated with fenfluramine= , including patients without a history of hypertension. In clinical trials = for DS and LGS of up to 3 years in duration, no pediatric or adult patient = receiving FINTEPLA developed hypertensive crisis. Monitor blood pressure in= patients treated with FINTEPLA. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closur= e glaucoma. Consider discontinuing treatment with FINTEPLA in patients with= acute decreases in visual acuity or ocular pain. ADVERSE REACTIONS The most common adverse reactions observed in DS studies (incidence at leas= t 10% and greater than placebo) were decreased appetite; somnolence, sedati= on, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, mal= aise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure = increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tr= act infection; vomiting; decreased weight; fall; status epilepticus. The most common adverse reactions observed in the LGS study (incidence at l= east 10% and greater than placebo) were diarrhea; decreased appetite; fatig= ue; somnolence; vomiting. DRUG INTERACTIONS Strong CYP1A2, CYP2B6, or CYP3A Inducers: Coadministration with strong CYP1= A2, CYP2B6, or CYP3A inducers will decrease fenfluramine plasma concentrati= ons. If coadministration of a strong CYP1A2, CYP2B6, or CYP3A inducer with = FINTEPLA is necessary, monitor the patient for reduced efficacy and conside= r increasing the dosage of FINTEPLA as needed. If a strong CYP1A2, CYP2B6, = or CYP3A inducer is discontinued during maintenance treatment with FINTEPLA= , consider gradual reduction in the FINTEPLA dosage to the dose administere= d prior to initiating the inducer. Strong CYP1A2 or CYP2D6 Inhibitors: Coadministration with strong CYP1A2 or = CYP2D6 inhibitors will increase fenfluramine plasma concentrations. If FINT= EPLA is coadministered with strong CYP1A2 or CYP2D6 inhibitors, the maximum= daily dosage of FINTEPLA is 20 mg. If a strong CYP1A2 or CYP2D6 inhibitor = is discontinued during maintenance treatment with FINTEPLA, consider gradua= l increase in the FINTEPLA dosage to the dose recommended without CYP1A2 or= CYP2D6 inhibitors. If FINTEPLA is coadministered with stiripentol and a st= rong CYP1A2 or CYP2D6 inhibitor, the maximum daily dosage of FINTEPLA is 17= mg. USE IN SPECIFIC POPULATIONS Administration to patients with hepatic impairment is not recommended.=C2= =A0 To report SUSPECTED ADVERSE REACTIONS, contact Zogenix Inc. at 1-866-964-36= 49 (1-866-Zogenix) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information (https://zogenix.com/pi/Fintepla-pr= escribing-information.pdf) , including Boxed Warning, for additional import= ant information on FINTEPLA. Important Safety Information about FINTEPLA^=C2=AE=E2=96=BC=C2=A0in the EU = and EEA^4 Contraindications Hypersensitivity to the active substance or any of the excipients listed in= section 6.1. Aortic or mitral valvular heart disease. Pulmonary arterial h= ypertension. 4 Within 14 days of the administration of monoamine oxidase in= hibitors due to an increased risk of serotonin syndrome Special warnings and precautions for use Aortic or mitral valvular heart disease and pulmonary arterial hypertension Because of reported cases of valvular heart disease that may have been caus= ed by fenfluramine at higher doses used to treat adult obesity, cardiac mon= itoring must be performed using echocardiography. In the controlled clinica= l studies of fenfluramine for the treatment of Dravet syndrome, no valvular= heart disease was observed. Prior to starting treatment, patients must undergo an echocardiogram to est= ablish a baseline prior to initiating treatment (see section 4.3) and exclu= de any pre-existing valvular heart disease or pulmonary hypertension. Echocardiogram monitoring should be conducted every 6 months for the first = 2 years and annually thereafter. If an echocardiogram indicates pathologica= l valvular changes, a follow-up echocardiogram should be considered at an e= arlier timeframe to evaluate whether the abnormality is persistent. If path= ological abnormalities on the echocardiogram are observed, it is recommende= d to evaluate the benefit versus risk of continuing fenfluramine treatment = with the prescriber, caregiver, and cardiologist. If treatment is stopped because of aortic or mitral valvular heart disease,= appropriate monitoring and follow-up should be provided in accordance with= local guidelines for the treatment of aortic or mitral valvular heart dise= ase. With past use in higher doses to treat adult obesity, fenfluramine was repo= rted to be associated with pulmonary arterial hypertension. Pulmonary arter= ial hypertension was not observed in the clinical programme, but because of= the low incidence of this disease, the clinical trial experience with fenf= luramine is inadequate to determine if fenfluramine increases the risk for = pulmonary arterial hypertension in patients with Dravet syndrome. If echocardiogram findings are suggestive of pulmonary arterial hypertensio= n, a repeat echocardiogram should be performed as soon as possible and with= in 3 months to confirm these findings. If the echocardiogram finding is con= firmed suggestive of an increased probability of pulmonary arterial hyperte= nsion defined as =E2=80=9Cintermediate probability=E2=80=9D by the 2015 Eur= opean Society of Cardiology (ESC) and the European Respiratory Society (ERS= ) Guidelines, it should lead to a benefit-risk evaluation of continuation o= f Fintepla by the prescriber, carer, and cardiologist. If the echocardiogra= m finding, after confirmation, suggests of a high probability of pulmonary = arterial hypertension, as defined by the 2015 ESC and ERS Guidelines, it is= recommended fenfluramine treatment should be stopped. Decreased appetite and weight loss Fenfluramine can cause decreased appetite and weight loss (see section 4.8)= . An additive effect on decreased appetite can occur when fenfluramine is c= ombined with other anti-epileptic medicines, for example stiripentol. The d= ecrease in weight appears to be dose related. Most subjects resumed weight = gain over time while continuing treatment. The patient's weight should be m= onitored. A benefit risk evaluation should be undertaken prior to commencin= g treatment with fenfluramine in patients with a history of anorexia nervos= a or bulimia nervosa. Fintepla controlled access programme A controlled access programme has been created to 1) prevent off-label use = in weight management in obese patients and 2) confirm that prescribing phys= icians have been informed of the need for periodic cardiac monitoring in pa= tients taking Fintepla. Somnolence Fenfluramine can cause somnolence. Other central nervous system depressants, including alcohol, could potentia= te the somnolence effect of fenfluramine (see sections 4.5 and 4.7). Suicidal behaviour and ideation Suicidal behaviour and ideation have been reported in patients treated with= anti-epileptic medicines in several indications. A meta-analysis of random= ised placebo-controlled trials with anti-epileptic medicines that did not i= nclude fenfluramine has shown a small increased risk of suicidal behaviour = and ideation. The mechanism of this risk is not known, and the available da= ta do not exclude the possibility of an increased risk for fenfluramine. Pa= tients and caregivers of patients should be advised to seek medical advice = should any signs of suicidal behaviour and ideation emerge. Serotonin syndrome As with other serotonergic agents, serotonin syndrome, a potentially life-t= hreatening condition, may occur with fenfluramine treatment, particularly w= ith concomitant use of other serotonergic agents (including SSRIs, SNRIs, t= ricyclic antidepressants, or triptans); with agents that impair metabolism = of serotonin such as MAOIs; or with antipsychotics that may affect the sero= tonergic neurotransmitter systems (see sections 4.3 and 4.5). Serotonin syndrome symptoms may include mental status changes (eg, agitatio= n, hallucinations, coma), autonomic instability (eg, tachycardia, labile bl= ood pressure, hyperthermia), neuromuscular aberrations (eg, hyperreflexia, = incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, di= arrhoea). If concomitant treatment with fenfluramine and other serotonergic agents th= at may affect the serotonergic systems is clinically warranted, careful obs= ervation of the patient is advised, particularly during treatment initiatio= n and dose increases. Increased seizure frequency As with other anti-epileptic medicines, a clinically relevant increase in s= eizure frequency may occur during treatment with fenfluramine, which may re= quire adjustment in the dose of fenfluramine and/or concomitant anti-epilep= tic medicines, or discontinuation of fenfluramine, should the benefit-risk = be negative. Cyproheptadine Cyproheptadine is a potent serotonin receptor antagonist and may therefore = decrease the efficacy of fenfluramine. If cyproheptadine is added to treatm= ent with fenfluramine, patients should be monitored for worsening of seizur= es. If fenfluramine treatment is initiated in a patient taking cyproheptadi= ne, fenfluramine's efficacy may be reduced. Glaucoma Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma= . Discontinue therapy in patients with acute decreases in visual acuity. Co= nsider discontinuation if there is ocular pain and another cause cannot be = determined. Strong CYP1A2 or CYP2B6 inducers Co-administration with strong CYP1A2 inducers or CYP2B6 inducers may decrea= se fenfluramine plasma concentrations (see section 4.5). An increase in fenfluramine dosage should be considered when co-administere= d with a strong CYP1A2 or CYP2B6 inducer; the maximum daily dose should not= be exceeded. Excipients This medicinal product contains sodium ethyl para-hydroxybenzoate (E 215) a= nd sodium methyl para-hydroxybenzoate (E 219) which may cause allergic reac= tions (possibly delayed). It also contains sulfur dioxide (E 220) which may rarely cause severe hyper= sensitivity reactions and bronchospasm. Patients with rare glucose-galactose malabsorption should not take this med= icinal product. This medicinal product contains less than 1 mmol sodium (23 mg) per the max= imum daily dose of 12 mL, that is to say essentially 'sodium-free'. This medicinal product contains glucose which may be harmful to the teeth. Refer to the European Summary of Product Characteristics for other adverse = reactions and full prescribing information. Date of revision: 04 Nov 2021.= =C2=A0 https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-pr= oduct-information_en.pdf=C2=A0 =C2=A0=E2=96=BCThis medicinal product is subject to additional monitoring. = This will allow quick identification of new safety information. Healthcare = professionals are asked to report any suspected adverse reactions.=C2=A0 About NAYZILAM^=C2=AE (midazolam) nasal spray, CIV in the U.S.^5 NAYZILAM is a benzodiazepine indicated for the acute treatment of intermitt= ent, stereotypic episodes of frequent seizure activity (i.e., seizure clust= ers, acute repetitive seizures) that are distinct from a patient=E2=80=99s = usual seizure pattern in patients with epilepsy 12 years of age and older. NAYZILAM IMPORTANT SAFETY INFORMATION=C2=A0 CONTRAINDICATIONS NAYZILAM is contraindicated in patients with acute narrow-angle glaucoma. RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines, including NAYZILAM, and opioids may res= ult in profound sedation, respiratory depression, coma, and death. Reserve = concomitant prescribing of these drugs for patients for whom alternative tr= eatment options are inadequate. Limit dosages and durations to the minimum = required. Follow patients for signs and symptoms of respiratory depression = and sedation. ABUSE, MISUSE, AND ADDICTION The use of benzodiazepines, including NAYZILAM, exposes users to risks of a= buse, misuse, and addiction, which can lead to overdose or death. Abuse and= misuse of benzodiazepines commonly involve concomitant use of other medica= tions, alcohol, and/or illicit substances, which is associated with an incr= eased frequency of serious adverse outcomes. Before prescribing NAYZILAM an= d throughout treatment, assess each patient=E2=80=99s risk for abuse, misus= e, and addiction. DEPENDENCE AND WITHDRAWAL REACTIONS AFTER USE OF NAYZILAM MORE FREQUENTLY T= HAN RECOMMENDED The continued use of benzodiazepines may lead to clinically significant phy= sical dependence. The risks of dependence and withdrawal increase with long= er treatment duration and higher daily dose. Although NAYZILAM is indicated= only for intermittent use, if used more frequently than recommended, abrup= t discontinuation or rapid dosage reduction of NAYZILAM may precipitate acu= te withdrawal reactions, which can be life-threatening. For patients using = NAYZILAM more frequently than recommended, to reduce the risk of withdrawal= reactions, use a gradual taper to discontinue NAYZILAM. Risks of Cardiorespiratory Adverse Reactions Serious cardiorespiratory adverse reactions have occurred after administrat= ion of midazolam. Warn patients and caregivers about the risks of respirato= ry depression, cardiac and respiratory arrest. Respiratory depression was observed with the administration of NAYZILAM dur= ing clinical trials. Cardiac or respiratory arrest caused by NAYZILAM was n= ot reported during clinical trials. Central Nervous System Depression from Concomitant Use with Other Central N= ervous System Depressants, or Moderate or Strong CYP3A4 Inhibitors Drug products containing midazolam, including NAYZILAM, have a central nerv= ous system (CNS) depressant effect.=C2=A0 Risks from Concomitant Use with Other CNS Depressants NAYZILAM may cause an increased CNS-depressant effect when used with alcoho= l or other CNS depressants (e.g., opioids). Warn patients and caregivers th= at the use of NAYZILAM in combination with alcohol or other CNS depressant = drugs may increase the risk of hypoventilation, airway obstruction, desatur= ation, or apnea and may contribute to profound and/or prolonged drug effect= . Risks from Concomitant Use with Moderate or Strong CYP3A4 Inhibitors Concomitant use of NAYZILAM with moderate or strong CYP3A4 enzyme inhibitor= s may result in prolonged sedation because of a decrease in plasma clearanc= e of midazolam. Caution patients against engaging in hazardous occupations = requiring mental alertness, such as operating machinery, driving a motor ve= hicle or riding a bicycle until they have completely returned to their leve= l of baseline functioning. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including NAYZILAM, increase the risk of suicid= al thoughts or behavior in patients taking these drugs for any indication. = Monitor patients treated with NAYZILAM for the emergence or worsening of de= pression, suicidal thoughts or behavior, and/or any unusual changes in mood= or behavior. Advise patients and caregivers to be alert for these behavior= al changes and to immediately report them to the healthcare provider. Impaired Cognitive Function Midazolam, including NAYZILAM, is associated with a high incidence of parti= al or complete impairment of recall for several hours following an administ= ered dose. Counsel patients on when they can engage in activities requiring= complete mental alertness, operate hazardous machinery, or drive a motor v= ehicle after taking NAYZILAM. Glaucoma Benzodiazepines, including NAYZILAM, can increase intraocular pressure in p= atients with glaucoma. NAYZILAM may be used in patients with open-angle gla= ucoma only if they are receiving appropriate therapy. NAYZILAM is contraind= icated in patients with narrow-angle glaucoma. ADVERSE REACTIONS In the randomized, double-blind, placebo-controlled trial, the most common = adverse reactions (=E2=89=A55% in any NAYZILAM treatment group) were somnol= ence, headache, nasal discomfort, throat irritation, and rhinorrhea. NAYZILAM is a Schedule IV controlled substance. Please refer to the full Prescribing Information (https://www.ucb-usa.com/n= ayzilam-prescribing-information.pdf) .=C2=A0 For additional medical information about NAYZILAM, patient assistance, or a= ny other information please visit our website (https://ucb-usa.com/Healthca= re-Professionals) or call UCBCares=C2=AE at 1-844-599-2273. About UCB0599 UCB0599 is an orally administered, brain penetrant, small molecule inhibito= r of ASYN misfolding under investigation for the potential use as a disease= -modifying treatment to slow the progression of PD.^6,7 UCB0599 was discove= red by NeuroPore and was licenced to UCB in 2014 for further development.^6= In 2021, UCB entered into a global co-development and co-commercialization= agreement with Novartis covering UCB0599.^8 For further information, contact UCB:=C2=A0 Investor Relations Antje Witte T +32.2.559.9414 [e-mail] Corporate Communications Corporate Communications Laurent Schots, Media Relations T+32.2.559.9264 [e-mail]=C2=A0=C2=A0 =C2=A0 Nick Francis=C2=A0 T [phone] [e-mail] Allyson Funk (U.S. Media) T [phone] [e-mail]=C2=A0=C2=A0 =C2=A0 About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With approximately 8 600 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Foll= ow us on Twitter: @UCB_news. Forward looking statements UCB=C2=A0 This press release contains forward-looking statements including, without l= imitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =E2= =80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=E2= =80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestimate= s=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccontinu= e=E2=80=9D and similar expressions. These forward-looking statements are ba= sed on current plans, estimates and beliefs of management. All statements, = other than statements of historical facts, are statements that could be dee= med forward-looking statements, including estimates of revenues, operating = margins, capital expenditures, cash, other financial information, expected = legal, arbitration, political, regulatory or clinical results or practices = and other such estimates and results. By their nature, such forward-looking= statements are not guarantees of future performance and are subject to kno= wn and unknown risks, uncertainties and assumptions which might cause the a= ctual results, financial condition, performance or achievements of UCB, or = industry results, to differ materially from those that may be expressed or = implied by such forward-looking statements contained in this press release.= Important factors that could result in such differences include: changes i= n general economic, business and competitive conditions, the inability to o= btain necessary regulatory approvals or to obtain them on acceptable terms = or within expected timing, costs associated with research and development, = changes in the prospects for products in the pipeline or under development = by UCB, effects of future judicial decisions or governmental investigations= , safety, quality, data integrity or manufacturing issues; potential or act= ual data security and data privacy breaches, or disruptions of our informat= ion technology systems, product liability claims, challenges to patent prot= ection for products or product candidates, competition from other products = including biosimilars, changes in laws or regulations, exchange rate fluctu= ations, changes or uncertainties in tax laws or the administration of such = laws, and hiring and retention of its employees. There is no guarantee that= new product candidates will be discovered or identified in the pipeline, o= r that new indications for existing products will be developed and approved= . Movement from concept to commercial product is uncertain; preclinical res= ults do not guarantee safety and efficacy of product candidates in humans. = So far, the complexity of the human body cannot be reproduced in computer m= odels, cell culture systems or animal models. The length of the timing to c= omplete clinical trials and to get regulatory approval for product marketin= g has varied in the past and UCB expects similar unpredictability going for= ward. Products or potential products which are the subject of partnerships,= joint ventures or licensing collaborations may be subject to disputes betw= een the partners or may prove to be not as safe, effective or commercially = successful as UCB may have believed at the start of such partnership. UCB= =E2=80=99 efforts to acquire other products or companies and to integrate t= he operations of such acquired companies may not be as successful as UCB ma= y have believed at the moment of acquisition. Also, UCB or others could dis= cover safety, side effects or manufacturing problems with its products and/= or devices after they are marketed. The discovery of significant problems w= ith a product similar to one of UCB=E2=80=99s products that implicate an en= tire class of products may have a material adverse effect on sales of the e= ntire class of affected products. Moreover, sales may be impacted by intern= ational and domestic trends toward managed care and health care cost contai= nment, including pricing pressure, political and public scrutiny, customer = and prescriber patterns or practices, and the reimbursement policies impose= d by third-party payers as well as legislation affecting biopharmaceutical = pricing and reimbursement activities and outcomes. Finally, a breakdown, cy= berattack or information security breach could compromise the confidentiali= ty, integrity and availability of UCB=E2=80=99s data and systems. =C2=A0 Given these uncertainties, you should not place undue reliance on any of su= ch forward-looking statements. There can be no guarantee that the investiga= tional or approved products described in this press release will be submitt= ed or approved for sale or for any additional indications or labelling in a= ny market, or at any particular time, nor can there be any guarantee that s= uch products will be or will continue to be commercially successful in the = future.=C2=A0 UCB is providing this information, including forward-looking statements, on= ly as of the date of this press release and expressly disclaims any duty to= update any information contained in this press release, either to confirm = the actual results or to report or reflect any change in its forward-lookin= g statements with regard thereto or any change in events, conditions or cir= cumstances on which any such statement is based, unless such statement is r= equired pursuant to applicable laws and regulations. =C2=A0 Additionally, information contained in this document shall not constitute a= n offer to sell or the solicitation of an offer to buy any securities, nor = shall there be any offer, solicitation or sale of securities in any jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction. =C2=A0 References 1. FINTEPLA^=C2=AE (Fenfluramine) CV. U.S. Prescribing Information (https:/= /zogenix.com/pi/Fintepla-prescribing-information.pdf) (Last accessed: March= 2022). 2. BRIVIACT^=C2=AE (brivaracetam) CV. U.S. Prescribing Information (https:/= /www.ucb-usa.com/briviact-prescribing-information.pdf) (Last accessed: Marc= h 2022). 3. European Medicines Agency. BRIVIACT=C2=AE (brivaracetam) Summary of Prod= uct Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/docu= ments/product-information/briviact-epar-product-information_en.pdf (Last ac= cessed: March 2022). 4. European Medicines Agency. FINTEPLA=C2=AE (Fenfluramine) Summary of Prod= uct Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/docu= ments/product-information/fintepla-epar-product-information_en.pdf. (Last a= ccessed: March 2022).=C2=A0 5. NAYZILAM^=C2=AE (midazolam) nasal spray CIV. U.S. Prescribing Informatio= n 6. UCB Initiates Phase 1b US-Based Multicenter Clinical Trial in Parkinson= =E2=80=99s Disease Patients with UCB0599, a Compound Arising from the Neuro= pore-UCB Collaboration. Available from: https://www.neuropore.com/media/new= s/neuropore-initiates-phase-1-clinical-trial-in-healthy-volunteers-with-npt= 52034-a-therapeutic-candidate-aimed-at-treating-parkinsons-disease-and-amyo= trophic-lateral-sclerosis9672.htm. (Last accessed: March 2022). 7. Smit JW, Maguire RP, Avbersek A et al. UCB0599 transition to the clinic:= An orally available brain-penetrant inhibitor of =CE=B1synuclein (ASYN) mi= sfolding in Phase 1 development for Parkinson=E2=80=99s disease (PD). MDS V= irtual Congress September 12=E2=80=9316 Late-breaking abstract 2020;LBA4. 8. UCB Announces Global Partnership to Bring Disease-Modifying Therapies to= People Living with Parkinson=E2=80=99s Disease. Available at: https://www.= ucb.com/stories-media/Press-Releases/article/UCB-Announces-Global-Partnersh= ip-to-Bring-Disease-Modifying-Therapies-to-People-Living-with-Parkinson-s-D= isease. (Last accessed: March 2022).=C2=A0 GenericFile 220401 AAN Curtain Raiser Press Release ENG (https://mb.cision.com/Public/1= 8595/3537505/b85e4b5866977e17.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x101246x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium