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Celgene Says FDA And EMA Accept Applications For Ozanimod

Celgene Corp. (CELG) said Thursday that the U.S. Food and Drug Administration or FDA has accepted for review the New Drug Application for ozanimod for the treatment of people with relapsing forms of multiple sclerosis or RMS in the U.S.

In addition, the European Medicines Agency or EMA has accepted for review the Marketing Authorization Application for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis or RRMS in the European Union.

The FDA and EMA applications are based primarily on ozanimod data from the SUNBEAM and RADIANCE Part B phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial.

Jay Backstrom, Chief Medical Officer for Celgene said, "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 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. Celgene said it expects a regulatory decision from the EMA in the first half of 2020.

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