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ArticleFDA Updates

FDA approves Ozanimod for Ulcerative Colitis

The US FDA has approved ozanimod (Zeposia) for adults with moderately to severely active ulcerative colitis (UC), the company has announced. Ozanimod (0.92 mg), an oral medication taken once daily, is the first sphingosine-1-phosphate (S1P) receptor modulator approved for UC.

In March 2020, the FDA approved ozanimod for adults with relapsing forms of multiple sclerosis

The approval, awarded to Bristol Myers Squibb, was based on the data from a placebo-controlled phase 3 trial dubbed True North. In the study, researchers evaluated ozanimod as a single, daily oral therapy for both adults and pediatric patients at least 12 years old with moderately to severely active ulcerative colitis.

More Info: FDA

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