FDA Advisory Committees Recommend Approval for Vedolizumab as Crohn’s, Ulcerative Colitis Treatment

Takeda Pharmaceuticals has announced that the Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees of the FDA have recommended approval for the company’s biologic vedolizumab as a treatment for Crohn’s disease and ulcerative colitis.

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All 21 committee members voted to approve the biologic as a treatment for ulcerative colitis and 20 of 21 committee members voted for approval as a Crohn’s disease treatment.

The advisory committees’ decision is non-binding, but will be taken into consideration when the FDA makes its decision on Takeda Pharmaceutical’s Biologics License Application for vedolizumab.

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