FDA and EMA accept for review ozanimod for the treatment relapsing-remitting multiple sclerosis

Celgene/BMS announced that the FDA has accepted for review the New Drug Application 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. Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).

Under the Prescription Drug User Fee Act, the FDA has set its action date as 25 March 2020. A regulatory decision from the EMA is expected in the first half of 2020. Both applications are based primarily on ozanimod data from the SUNBEAM and RADIANCE Part B phase III, multicenter, randomized, double-blind, double-dummy, active-controlled trials.