Celgene Corporation (CELG - Free Report) announced that the FDA has accepted for review the new drug application (NDA) for ozanimod for the treatment of people with relapsing forms of multiple sclerosis (RMS) in the United States. The European Medicines Agency (EMA) also accepted for review the Marketing Authorization Application for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) in the European Union.
The FDA has set an action date of Mar 25, 2020. A regulatory decision from the EMA is expected in the first half of 2020.
Shares of Celgene have surged 48.6% year to date compared with the industry’s growth of 0.3%.
The FDA and EMA applications are based primarily on ozanimod data from the SUNBEAM and RADIANCE Part B phase III studies.
The SUNBEAM study evaluated the efficacy, safety and tolerability of two doses of oral ozanimod against weekly intramuscular interferon beta-1a (Avonex) for at least a 12-month treatment period. The primary endpoint of the trial was annualized relapse rates (ARR) during the treatment period in 1346 participants with RMS.
In February 2017, Celgene announced positive top-line data from the SUNBEAM study, which revealed that both ozanimod treatment arms demonstrated statistically significant and clinically meaningful improvements compared with Avonex for the primary endpoint of ARR. The top-line data that Celgene announced in May 2017 from the RADIANCE study also showed that the primary endpoint and key secondary MRI endpoints were met.
However, in February 2018, the company received a Refusal to File letter from the FDA regarding its NDA for ozanimod for the treatment of people with RMS. Upon its preliminary review, the FDA determined that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review. The company then submitted a NDA again in March 2019 to the FDA based on data from the SUNBEAM and RADIANCE studies.
MS is a crowded market, with many companies already having drugs in their portfolio approved for this indication. Biogen (BIIB - Free Report) holds a strong position in the MS market with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy. Israel-based Teva Pharmceuticals (TEVA - Free Report) has long been in the MS market with its widely used drug, Copaxone, which is facing stiff generic competition for the past few years.
Novartis’ (NVS - Free Report) MS portfolio comprises approved drugs like Gilenya and Extavia for the treatment of RMS.
Celgene currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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