Bristol-Myers Squibb (BMY) Application for Zeposia for Treatment of Ulcerative Colitis Accepted for Filing with Priority Review by FDA

Go back to Bristol-Myers Squibb (BMY) Application for Zeposia for Treatment of Ulcerative Colitis Accepted for Filing with Priority Review by FDA

Bristol Myers Squibb Application for Zeposia® (ozanimod) for the Treatment of Ulcerative Colitis Accepted for Filing with Priority Review by U.S. Food and Drug Administration

February 1, 2021 6:59 AM EST

U.S. Food and Drug Administration assigned an action date of May 30, 2021

Supplemental New Drug Application is supported by positive results from the pivotal Phase 3 True North study evaluating oral Zeposia (ozanimod) in adults with moderately to severely active ulcerative colitis

If approved, Zeposia would be the first oral sphingosine-1-phosphate (S1P) receptor modulator for the treatment of ulcerative colitis

PRINCETON, N.J.--(BUSINESS... More