FDA approves ozanimod for treatment in adults with relapsing forms of MS

The US Food and Drug Administration (FDA) approved ozanimod (Zeposia®) for adults with relapsing forms of multiple sclerosis (relapsing-remitting MS and active secondary progressive MS).

Ozanimod is an oral sphingosine-1-phosphate (S1P) receptor modulator that works by entering the central nervous system (CNS) and binding to specific subtypes (S1P1R and S1P5R) of the sphingosine 1-phosphate (S1P) receptor. The S1P receptor is found on the surface of specific immune cells called T cells and B cells that play a role in causing damage to the CNS in MS. By binding to the S1P receptor, ozanimod prevents harmful immune cells – specifically B cells and T cells – from being activated and released from the lymph nodes and thymus gland into the blood circulation and, hence, the brain and spinal cord.

The FDA’s approval was based on two phase three trials, RADIANCE and SUNBEAM. RADIANCE phase III trial recruited 1,313 individuals at 147 sites in 21 countries. Participants received either ozanimod (0.5 mg or 1mg) daily, a weekly injection of interferon beta-1a (Avonex®), or placebo for two years. Both doses of ozanimod met the primary endpoint which was a reduction in the annualized relapse rate compared to interferon beta-1a.

SUNBEAM, a phase III randomized, double-blind clinical trial, assessed the efficacy, and safety of ozanimod (0.5 mg or 1mg) compared to interferon beta-1a over the course of 12-months. Researchers recruited 1,346 individuals with RRMS across 152 sites and 20 countries. The clinical trial met its primary endpoint of reducing annualized relapse rates compared with interferon beta-1a. Treatment with ozanimod also resulted in less new and enlarging lesions compared to interferon beta-1a.

Bristol Myers Squibb has submitted a drug marketing application for ozanimod to Health Canada. It is currently under review. The MS Society will continue to provide updates on Health Canada approval and drug access as they become available.