Posted by Michael Wonder on 26 Mar 2019
Celgene submits application to FDA for ozanimod for the treatment of relapsing forms of multiple sclerosis
25 March 2019 - Celgene Corporation today announced that the Company has submitted a new drug application to the U.S. FDA for ozanimod for the treatment of adults with relapsing forms of 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, multi-centre, randomised, double-blind, double-dummy, active-controlled trials.
