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FDA Advisors Recommend Approval of Bowel Disease Drug Vedolizumab

Experts say benefits outweigh risks (December 9)

A joint panel of members from the FDA’s Gastrointestinal Drugs and Drug Safety and Risk Management advisory committees have voted to recommend approval of vedolizumab (Takeda) 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 had not responded to steroids or immunosuppressants or tumor necrosis factor (TNF)-alpha antagonists, whereas eight committee members supported approval for UC patients who have did not respond to immunosuppressants or TNF-alpha antagonists. (The indicated population would not include patients who had failed to respond to steroids only).

Twenty of the 21 committee members voted to support approval for CD. Specifically, 14 committee members supported approval for CD patients who did not respond to steroids or immunosuppressants or TNF-alpha antagonists, whereas six supported approval for CD patients who did not respond to immunosuppressants or TNF-alpha antagonists. (The indicated population would not include patients did not respond to steroids only).

The outcome of the advisory committee meeting will be taken into consideration by the FDA when making its decision on the Biologics License Application (BLA) for vedolizumab, which was submitted in June 2013.

Vedolizumab is a humanized monoclonal antibody that specifically antagonizes the alpha4beta7 integrin, thereby inhibiting the binding of alpha4beta7 to intestinal mucosal addressin-cell adhesion molecule 1 (MAdCAM-1). MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. The alpha4beta7 integrin is expressed on a subset of circulating white blood cells. These cells play a role in mediating the inflammatory process in UC and CD. By inhibiting alpha4beta7, vedolizumab may limit the ability of certain lymphocytes to infiltrate gut tissues.

Source: PR Newswire; December 9, 2013.

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