FDA Advisory Committe recommends vedolizumab for Crohns disease and Ulcerative Colitis-Takeda

Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., announced that a joint panel of members from the Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees of the FDA 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 currently available 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-alpha antagonists, while eight committee members supported approval for UC patients who have failed immunosuppressants or TNF-? antagonists (the indicated population would not include patients that failed steroids only). Twenty 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-? antagonists while six supported approval for CD patients who have failed immunosuppressants or TNF-? antagonists (the indicated population would not include patients that failed steroids. only.

The BLA filings were supported by the GEMINI Studies, a four-study clinical program investigating vedolizumab in 2,700 patients in nearly 40 countries, making it the largest Phase III clinical trial program conducted to date simultaneously evaluating both UC and CD patient populations.