Celgene Corporation today 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 3, multicenter, randomized, double-blind, double-dummy, active-controlled trials.
The Company remains on track to submit a New Drug Application to the U.S. Food and Drug Administration for relapsing forms of MS (RMS) by the end of March.
Celgene believes ozanimod could be a best-in-class, oral option for use early in the treatment of relapsing forms of multiple sclerosis. We look forward to regulatory review and the potential for ozanimod to improve the lives of people with this disease,
said Jay Backstrom, M.D.,
Chief Medical Officer for Celgene.
Ozanimod is an investigational compound that is not approved for any use in any country.