The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ozanimod (Celgene), an investigational treatment for relapsing forms of multiple sclerosis (MS).

Ozanimod is an oral sphingosine 1-phosphate (S1P) receptor modulator that works by binding with high affinity selectively to S1P subtypes 1 and 5. The NDA includes data from the phase 3, randomized SUNBEAM and RADIANCE Part B trials.

In SUNBEAM (N=1346), a significant reduction in annualized relapse rates (ARR; primary endpoint) was observed with ozanimod 0.5mg (P =.0013) and 1mg (P <0.0001) vs interferon beta-1a over an average treatment duration of 13.6 months. RADIANCE Part B (N=1320) also evaluated ozanimod 0.5mg and 1mg vs interferon beta-1a. Both ozanimod doses showed statistically significant and clinically meaningful reductions in ARR over 24 months (primary endpoint).

Ozanimod is also currently being assessed in a phase 3 ulcerative colitis trial and a phase 2 Crohn disease trial.

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“We believe that ozanimod has the potential to be an important option early in the treatment of relapsing forms of MS and a best-in-class S1P receptor modulator,” said Jay Backstrom, MD, CMO for Celgene. A Prescription Drug User Fee Act (PDUFA) date of March 25, 2020 has been set for this application.

In March 2019, the FDA approved the S1P receptor modulator siponimod (Mayzent; Novartis) for the treatment of relapsing forms of MS.

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