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BRIEF-FDA panel backs Takeda drug for ulcerative colitis, Crohn's disease
December 9, 2013 / 10:36 PM / 4 years ago

BRIEF-FDA panel backs Takeda drug for ulcerative colitis, Crohn's disease

Dec 9 (Reuters) - Takeda Pharmaceutical Co Ltd : * FDA advisory panel votes 12-9 that available data for Takeda Pharmaceutical

co’s vedolizumab support its efficacy for Crohn’s disease induction

therapy * FDA advisory panel votes 19-1 that data for Takeda’s vedolizumab

support its efficacy for crohn’s disease maintenance therapy * FDA panel votes 21-0 that Takeda has sufficiently characterized risk of PML

with vedolizumab to suport crohn’s disease approval * FDA panel votes 19-1 that if Takeda’s vedolizumab is approved for Crohn’s

disease use of concomitant immunosuppressants should not be limited in

duration * FDA panel votes 21-0 that benefits of Takeda’s vedolizumab outweigh risks,

support approval for ulcerative colitis in patients not helped by prior

therapies * FDA panel votes 20-1 that benefits of Takeda’s vedolizumab outweigh risks,

support approval for Crohn’s disease in patients not helped by prior

therapies

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