Celgene submits MAA to EMA for ozanimod to treat relapsing-remitting multiple sclerosis
Celgene Corporation announced that the Company has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS). Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).
The pivotal efficacy and safety data provided in the application result from the SUNBEAM and RADIANCE Part B phase III, multicenter, randomized, double-blind, double-dummy, active-controlled trials. The Company remains on track to submit a New Drug Application to the FDA for relapsing forms of MS (RMS) by the end of March 2019.
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