Bristol-Myers Squibb Co. received approval from the U.S. FDA for 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.
ZEPOSIA, an oral medication taken once daily, is the only approved sphingosine-1-phosphate (S1P) receptor modulator that offers RMS patients an initiation with no genetic test and no label-based first-dose observation required for patients.
Multiple sclerosis (MS) is a disease in which the immune system attacks the protective myelin sheath that covers the nerves, creating damaging lesions that make it harder for signals to travel between each nerve cell. This "signal breakdown" can lead to symptoms and relapses.
The approval is based on data from head-to-head RMS studies with an active comparator assessing the safety and efficacy of ZEPOSIA as compared to Biogen's AVONEX (interferon beta-1a).
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