Bristol-Myers Squibb Company announced that the European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. With the EC marketing authorization, Zeposia, an oral medication taken once daily, becomes the only approved sphingosine-1-phosphate (S1P) receptor modulator for RRMS patients with active disease. The approval is based on data from the SUNBEAM™ and RADIANCE™ Part B clinical trials showing that, as compared to AVONEX® (interferon beta-1a), Zeposia delivered powerful efficacy as measured by annualized relapse rate (ARR), as well as on the number and size of brain lesions. Multiple sclerosis (MS)is a disease in which the immune system attacks the protective myelin sheath that covers the nerves, creating damaging lesions that make it harder for signals to travel between each nerve cell. This “signal breakdown” can lead to symptoms and relapses. The approval was based on data from the randomized, active-controlled Phase 3 SUNBEAM and RADIANCE Part B clinical trials, which enrolled more than 2,600 patients across 150 sites in more than 20 countries.Key findings from the trials include: Zeposia demonstrated a relative reduction in ARR versus AVONEX of 48% through one year in the SUNBEAM study and 38% at two years in the RADIANCE study (absolute ARR of 0.18 versus 0.35 and 0.17 versus 0.28, respectively). At one year in the SUNBEAM study, treatment with Zeposia reduced the number of T1-weighted gadolinium-enhanced (GdE) brain lesions more than AVONEX (0.16 vs 0.43), a relative reduction of 63%, and reduced the number of new or enlarging T2 brain lesions (1.47 versus 2.84), a relative reduction of 48%. At two years in the RADIANCE study, treatment with Zeposia reduced the number of T1-weighted GdE brain lesions more than AVONEX (0.18 versus 0.37), a relative reduction of 53%. Zeposia also reduced the number of new or enlarging T2 lesions versus AVONEX (1.84 versus 3.18), a relative reduction of 42%. Zeposia demonstrated a reduction in percent change from baseline in whole brain volume as compared to AVONEX at one year in the SUNBEAM study (-0.41% versus -0.61%) and at two years in the RADIANCE study (-0.71% versus -0.94%). Zeposia is the only approved S1P receptor modulator that offers RRMS patients with active disease an initiation with no first-dose observation required for the majority of patients.1 First-dose monitoring is only recommended for high-risk patients with certain pre-existing cardiac conditions. A dose escalation regimen from day 1 to day 7 should be used to reach the maintenance dose of Zeposia, as a transient decrease in heart rate and atrioventricular conduction delays may occur.