Bristol Myers Squibb Co. on Monday said the U.S. Food and Drug Administration accepted its application for expanded use of Zeposia in adults with moderately to severely active ulcerative colitis.
The New York biopharmaceutical company said it redeemed a priority-review voucher with the submission, resulting in an FDA target action date of May 30.
Bristol Myers said Zeposia, if approved, would be the first oral sphingosine-1-phosphate receptor modulator for the treatment of ulcerative colitis, a chronic inflammatory bowel disease.
Bristol Myers last year received U.S. and European approval for Zeposia in adults with relapsing forms of multiple sclerosis. The company is also evaluating the drug as a treatment for Crohn's disease.
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