FDA advisory panel backs approval of Takeda’s vedolizumab
A US Food and Drug Administration advisory committee has recommended approval of vedolizumab from Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502).
A joint panel of members from the FDA’s Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees voted to recommend approval of vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). All 21 committee members voted that based on efficacy and safety data, the benefits outweigh the potential risks of vedolizumab to support approval for UC.
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