Ozanimod to treat adult patients with active MS

June 10, 2020 0 By FM

Bristol Myers Squibb announced that the European Commission (EC) has approved ozanimod (Zeposia) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease. 

With the EC marketing authorisation, ozanimod, an oral medication taken once daily, becomes the only approved sphingosine-1-phosphate (S1P) receptor modulator for RRMS patients with active disease. 

The approval is based on data from the SUNBEAM and RADIANCE Part B clinical trials showing that, as compared to interferon beta-1a, ozanimod delivered powerful efficacy as measured by annualised relapse rate (ARR), as well as on the number and size of brain lesions.

SUNBEAM is a pivotal, phase 3, multicentre, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral Zeposia (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI, respectively) against weekly intramuscular interferon beta-1a for at least a 12-month treatment period. The study included 1,346 people living with relapsing forms of multiple sclerosis (RMS) across 152 sites in 20 countries.