Celgene’s Investigational MS Agent Reduces Annual Relapse Rate but Falls Short of Disability Endpoint in Phase 3 Trial

 

New Phase 3 findings suggest that Celgene’s investigational ozanimod for relapsing multiple sclerosis (MS) reduces annualized relapse rate in a clinically meaningful way but does not significantly impact disease disability. In the RADIANCE trial, 1,313 patients with relapsing MS were randomized to receive either 0.5 mg or 1 mg of ozanimod, a sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, or weekly interferon beta-1a (Avonex), over a two-year period. Both doses of ozanimod demonstrated significant and clinically meaningful reductions in the annualized relapse rate versus Avonex, while the oral selective S1P 1 and 5 receptor modulator also achieved significance for the two key secondary endpoints.

However, ozanimod was not associated with a significant difference in the rate of disease progression versus Avonex, based on a pre-specified pooled analysis of data from the RADIANCE trial and the late-stage SUNBEAM study reported earlier this year.

Celgene is expected to submit a New Drug Application to the FDA later this year.

 

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