The FDA accepts applications for new drugs to treat multiple sclerosis

recently, Celgene announced that the FDA has accepted a new drug application (NDA) for Ozanimod's treatment of multiple sclerosis (RMS), and the European Medicines Agency (EMA) has accepted a market license (MAA) for ozanimod's treatment of relapsed relapsed multiple sclerosis (RRMS).about ozanimod ozanimod is an oral 1-phosphate arginol (S1P) subject regulator that selectively binds to S1P subtype 1 (S1P1) and subtype 5 (S1P5) with high affinity. Under the Prescription Drug User Charge Act (PDUFA), the FDA will make a review decision on March 25, 2020. The EMA is expected to make a review decision in the first half of 2020.is the core asset of The New Base's $7.3 billion acquisition of Receptos in 2015. On U.S. regulatory grounds, Ozanimod was rejected by the FDA earlier in 2018 on the grounds that non-clinical and clinical pharmacological evidence was insufficient to allow the review to pass.related studiesThis NDA and MAA is based on 2 multi-center, randomized, double-blind, dual-analog, positive drug-controlled Phase III clinical studies of SUNBEAM and RADIANCE Part B efficacy and safety data.at the end of March, Novartis' oral drug Mayzent (siponimod) was approved by the FDA for treatment in adult RMS patients, including active secondary progressive multiple sclerosis (SPMS), relapsed remissive multiple sclerosis (RRMS), and clinical isolation syndrome (CIS). Mayzent is the first and only therapeutic drug specifically approved for active SPMS patients in the past 15 years, with the active drug ingredient siponimod, a new generation, selective 1-phosphate arginol (S1P) regulator that selectively binds to S1P1 and S1P5 binders and has the same mechanism of action as the new kizanimod. (Drug Advisory Network)