Posted by Michael Wonder on 11 Mar 2019
Celgene submits application to EMA for ozanimod for the treatment of relapsing-remitting multiple sclerosis
11 March 2019 - New drug application submission to U.S. FDA on track for end of March.
Celgene Corporation today announced that the Company has submitted a marketing authorisation application to the EMA for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis. 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, randomised, double-blind, double-dummy, active-controlled trials.
