Bristol Myers Squibb's Multiple Sclerosis Drug, a Potential Blockbuster, Wins FDA Approval
Bristol Myers Squibb (NYSE: BMY) announced on Thursday that the Food and Drug Administration has approved Zeposia (ozanimod) for treating adults with relapsed multiple sclerosis (MS), an autoimmune disease where the body's immune system attacks the protective myelin sheathes that cover its nerves. The FDA approval was based on two large late-stage clinical studies in which Zeposia demonstrated higher efficacy than Biogen's MS drug Avonex.
Celgene first filed for FDA approval of ozanimod in 2018. However, the FDA sent the biotech a Refusal to File letter stating that the application for the drug wouldn't even be considered because the submission didn't include all of the required information for a review.
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Source Fool.com
