Celgene Corporation announced that the company has submitted a Marketing Authorization Application to the European Medicines Agency for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis. Ozanimod is an oral, sphingosine 1-phosphate receptor modulator, which binds with high affinity selectively to S1P subtypes 1 and 5. 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 by the end of March. Ozanimod is an investigational compound that is not approved for any use in any country.
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