Bristol Myers Squibb announced Thursday that the FDA approved Zeposia (ozanimod) for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. However, the company noted that given the COVID-19 pandemic and the pressure it is placing on the US healthcare system, it will delay commercialising the S1P receptor modulator.
According to Bristol Myers Squibb, which gained Zeposia via last year's $74-billion purchase of Celgene, the once-daily oral medicine is the only approved S1P receptor modulator that offers RMS patients an initiation with no genetic test and no label-based first-dose observation required for patients. The deal for Celgene included a contingent value right worth up to $9 per share linked to FDA approval of three therapies, specifically Zeposia and liso-cel by the end of 2020 and bb2121 by March 31, 2021.
The FDA approval of Zeposia is based on data from the Phase III SUNBEAM and RADIANCE Part B studies, with results showing that the drug demonstrated a relative reduction in annualised relapse rate versus Biogen's Avonex (interferon beta-1a) of 48% through one year and 38% at two years. Meanwhile, Zeposia reduced the number of T1-weighted gadolinium-enhanced brain lesions by 63% compared to Avonex at one year and by 53% at two years.
A marketing application for the drug for the treatment of adults with relapsing-remitting MS is currently under review by the European Medicines Agency, with a decision expected in the first half of 2020. Bristol Myers Squibb is also investigating Zeposia for additional immune-inflammatory indications, including ulcerative colitis and Crohn's disease.
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