Ozanimod to treat adult patients with active MSJune 10, 2020
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.