Posted by Michael Wonder on 26 Mar 2020
U.S. FDA approves Bristol Myers Squibb’s Zeposia (ozanimod), a new oral treatment for relapsing forms of multiple sclerosis
26 March 2020 - In clinical trials, Zeposia demonstrated efficacy on a key clinical marker of disease activity – annualised relapse rate (ARR) – as compared to Avonex (interferon beta-1a).
Bristol-Myers Squibb today announced that the U.S. FDA approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
The approval is based on data from the largest pivotal, head-to-head RMS studies with an active comparator to date: the randomised, active-controlled Phase 3 SUNBEAM (safety and efficacy of Zeposia versus interferon beta-1a in relapsing multiple sclerosis) and Radiance (safety and efficacy of the selective sphingosine 1-phosphate receptor modulator Zeposia in relapsing multiple sclerosis) Part B clinical trials of more than 2,600 adults.
