Report highlights personalized medicines ensuring greater efficacy for rare diseases and previously untreatable conditions
Promising therapeutic developments for HIV, Parkinson's disease, Crohn's disease, alopecia, multiple myeloma and breast cancer on horizon
The Drugs to Watch 2023 list from Clarivate primarily features treatments targeted to a particular biomarker, ensuring greater efficacy and less precious time lost searching for a drug or biologic that will arrest or reverse the progress of disease. Personalized medicines have begun to evolve from promise to reality, accounting for more than 25% of FDA approvals for the last seven years1. The rise of personalized medicine has resulted in success beyond oncology and rare diseases, facilitating therapies for formerly untreatable conditions.
The report also highlights potential blockbusters in Mainland China. Clarivate identified nine drugs that are likely to achieve
In addition, the report examines the industry's progress in addressing the diseases highlighted in the United Nations Sustainable Development Goals. These goals address infectious diseases such as tuberculosis, malaria, neglected tropical diseases and water-borne diseases, as well as maternal mortality and non-communicable diseases like mental illness and substance abuse.
Among new drugs and biologics that have either won approval or are poised to, Clarivate has identified 15 treatments likely to achieve blockbuster status in the next five years or transform paradigms to meet unmet patient needs. The 2023 Drugs to Watch, are:
Bimekizumab (BIMZELX®) developed by UCB- Bimekizumab is the first dual IL-17 A/F inhibitor to treat moderate to severe plaque psoriasis. Phase 3 trial results showed superior skin clearance outcomes than existing treatments. Its less-frequent dosing schedule and good safety profile will likely be attractive to clinicians and patients.
Capivasertib (AZD5363) developed by AstraZeneca- For patients with breast cancer, Capivasertib is a novel, highly potent, selective ATP-competitive pan-AKT kinase inhibitor that exerts similar activity against the three isoforms AKT1, AKT2 and AKT3. Positive data have emerged from early-phase trials, with clinical benefit to patients irrespective of their PIK3CA/AKT1/PTEN mutational status, and several phase 3 trials are now underway.
Daprodustat (GSK1278863/Duvroq) developed by GSK plc.- Daprodustat belongs to a novel class of oral treatments for chronic kidney disease (CKD)-related anemia and is a HIF-PHI developed to treat anemia associated with CKD, which has a high incidence rate and few effective, safe treatment options. Already available for CKD-related anemia in
Deucravacitinib (SOTYKTU™/BMS-986165) developed by Bristol Myers Squibb- As a first-in-class oral, targeted agent that selectively inhibits tyrosine kinase 2 (TYK2), a Janus kinase (JAK) family member that mediates cytokine-driven immune and inflammatory signals, it has the potential to fill a gap in the treatment armamentarium for plaque psoriasis.
Foscarbidopa/foslevodopa (ABBV-951) developed by AbbVie- Foscarbidopa/foslevodopa is a novel reformulation of the gold-standard Parkinson's disease treatment (carbidopa/levodopa) delivered via a subcutaneous pump for the treatment of motor fluctuations in advanced Parkinson's disease. In addition to serving a niche group of patients with high unmet need, it offers better efficacy than orally administered carbidopa-levodopa, dosing flexibility and a more convenient pump than existing and upcoming competitors.
LEQEMBI™ (BAN2401) developed by Eisai Co Ltd and Biogen Inc, and Donanemab (LY-3002813), developed by Eli Lilly and Company- LEQEMBI and Donanemab are poised to help treat early-stage Alzheimer's disease. Supported by landmark clinical data from a phase 3 trial, next-in-class anti-Aβ monoclonal antibody (MAb) LEQEMBI has recently received accelerated approved by the
Lenacapavir (Sunlenca®/GS-6207) developed by Gilead Sciences Inc.- Approved in
Mirikizumab (LY-3074828) developed by Eli Lilly and Company -Mirikizumab, a monoclonal antibody targeting the p19 subunit of IL-23, will likely be first-in-class for ulcerative colitis and the third in the class approved for Crohn's disease. Part of a set of emerging therapies with novel mechanisms of action, it will contribute to the growing market share held by these therapies.
Pegcetacoplan (EMPAVELI®/ASPAVELI®/APL-2) developed by Apellis Pharmaceuticals Inc. - Pegcetacoplan has launched already in
Ritlecitinib (PF-06651600) developed by Pfizer Inc.- Ritlecitinib will likely benefit from its first-in-class status, rapid onset of action and expected label for both adults and adolescents, potentially providing an effective option to stimulate hair growth in a stigmatizing disease - Alopecia areata.
Sparsentan developed by Travere Therapeutics Inc - Sparsentan is a first-in-class, orally active, single molecule that functions as a high-affinity, dual-acting antagonist of both endothelin type A (ETA) and angiotensin II subtype 1 (AT1) receptors, which are associated with progression of kidney disease. Its development for IgA nephropathy and focal segmental glomerulosclerosis (FSGS) promises to halt that progression for many patients and fills a gap in the treatment armamentarium.
Teclistamab (TECVAYLI®/JNJ-64007957) developed by Janssen Pharmaceutical Companies of Johnson & Johnson - After receiving conditional approval from the EC (
Teplizumab (TZIELD™/PRV-031) developed by Provention Bio Inc- Teplizumab is the first immunotherapy to launch for T1DM and is a landmark drug given its potential ability to preserve beta cell function and delay the need for insulin treatment in those with type 1 diabetes mellitus (T1DM).
Valoctocogene roxaparvovec (ROCTAVIAN™/BMN-270) developed by BioMarin Pharmaceutical Inc - Approved by the
Despite the many urgent challenges life science companies will face in 2023, from patent cliffs to capital investment, the industry is on the cusp of unlocking revolutionary technologies that could greatly advance human health.
Access the Drugs to Watch 2023 report from Clarivate, here.
For more Drugs to Watch updates and analyses throughout the year, visit the Drugs to Watch web page and follow Clarivate for Life Sciences & Healthcare on LinkedIn and
To learn more about how Clarivate can help healthcare companies inform and shape the drug discovery, development and delivery process, join Dr.
To learn more about Clarivate data products, visit www.clarivate.com.
Increasingly, companies are targeting smaller patient populations with more targeted drugs, many of which will garner less revenue than the mass-market drugs that have traditionally formed the bread and butter of large pharmas but which stand to greatly advance patient care. Accordingly, Clarivate revised its methodology to recognize late-stage developmental therapeutics of clinical and commercial notes.
To identify this year's Drugs to Watch, Clarivate drew from the expertise of over 160 analysts covering hundreds of diseases, drugs and markets and eleven integrated data sets that span the R&D and commercialization lifecycle, including: Cortellis Competitive Intelligence™, Disease Landscape & Forecast, BioWorld™, Drug Timeline & Success Rates, Cortellis Clinical Trials Intelligence™, Cortellis Generics Intelligence™, Cortellis Deals Intelligence™, Access & Reimbursement payer studies, Clarivate Real World Data and Analytics, Web of Science™ Derwent Innovation™ and other industry sources including biopharma company press releases, filings and peer-reviewed publications. Candidate drugs in phase 2 or phase 3 trials, at pre-registration or registration stage, or already launched early in 2022 were selected for analysis, including those pursuing new indications that could be particularly impactful; drugs launched prior to 2022 were excluded. The dataset was filtered for drugs that had total forecast sales of
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