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.

Specifically, 13 committee members supported approval for UC patients who have failed steroids or immunosuppressants or TNF-α antagonists, while eight committee members supported approval for UC patients who have failed immunosuppressants or TNF-alpha antagonists (the indicated population would not include patients that failed steroids only). Some 20 of the 21 committee members voted to support approval for CD. Specifically, 14 committee members supported approval for CD patients who have failed steroids or immunosuppressants or TNF-alpha antagonists while six supported approval for CD patients who have failed immunosuppressants or TNF-alpha antagonists (the indicated population would not include patients that failed steroids only).