US FDA and EMA Accept Applications for Celgene MS Med

Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (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 March 25, 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.

“The U.S. Food and Drug Administration and European Medicines Agency acceptances of our applications represent a crucial step forward in our efforts to bring ozanimod to people with multiple sclerosis,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “We believe that ozanimod has the potential to be an important option early in the treatment of relapsing forms of MS and a best-in-class S1P receptor modulator.”

Ozanimod is an investigational compound that is not approved for any use in any country.

https://www.biospace.com/article/releases/us-fda-and-ema-accept-applications-for-ozanimod-for-the-treatment-of-relapsing-forms-of-multiple-sclerosis/