Celgene submts application to FDA for ozanimod
Celgene announced that the company has submitted a New Drug Application to the FDA for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis, or RMS. 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. Earlier this month, the company also submitted a Marketing Authorization Application to the European Medicines Agency for adults with relapsing-remitting multiple sclerosis. Ozanimod is an investigational compound that is not approved for any use in any country.