Celgene NDA for Ozanimod for Relapsing Multiple Sclerosis

FDA has accepted a Celgene NDA for ozanimod, indicated for treating patients with relapsing forms of multiple sclerosis (RMS). The oral, sphingosine 1-phosphate (S1P) receptor modulator binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). The submission is based on data from the SUNBEAM and RADIANCE Part B phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trials. FDA has set a user fee review action target of 3/25/2020.

Ozanimod causes lymphocyte retention in lymphoid tissues, according to Celgene. “The mechanism by which ozanimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve the reduction of lymphocyte migration into the central nervous system,” it says. Ozanimod is in development for immune-inflammatory indications including RMS, ulcerative colitis and Crohn's disease.