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FDA Committee Recommends Approval of Vedolizumab

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FDA Committee Recommends Approval of Vedolizumab

Takeda announces positive vote on vedolizumab to treat ulcerative colitis and Crohn's disease

FDA Committee Recommends Approval of Takeda’s Investigational Biologic Vedolizumab, DEERFIELD, Ill. and OSAKA, Japan, Dec. 9, 2013 weneedideas.ca Takeda Pharmaceutical Company Limited (“Takeda”) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that a joint panel of members from the Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees of the United States (U.S.) Food and Drug Administration (FDA) voted to recommend approval of Takeda’s vedolizumab for the treatment of adults with moderately to severely active (UC) and Crohn’s disease (CD).

Takeda
Takeda

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-alpha 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-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).

We are very pleased with the advisory committee’s recommendation. People with ulcerative colitis or Crohn’s disease are in need of additional treatment options, as many patients lose response to currently available treatments, said Asit Parikh, M.D., Ph.D., vice president, general medicine, Takeda. Vedolizumab was designed to treat inflammation in the GI tract, and if approved, may offer an additional option for patients suffering from ulcerative colitis or Crohn’s disease.

FDA Advisory Committee Recommends Approval of Takeda’s Investigational Biologic Vedolizumab

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