6 June 2019 - Celgene Corporation today announced that the U.S. FDA has accepted for review the new drug application for ozanimod for the treatment of people with relapsing forms of multiple sclerosis in the United States. 

The EMA also accepted for review the marketing authorisation application for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis 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 3, multicenter, randomized, double-blind, double-dummy, active-controlled trials.

Read Celgene press release