Takeda’s IBD drug wins FDA backing

Takeda’s inflammatory bowel disease drug vedolizumab, a gut-selective, anti-inflammatory monoclonal antibody, has been recommended for US regulatory approval for use in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

The US Food and Drug Administration (FDA) advisory committee has voted in favour of the drug after a priority review of late-stage clinical trials showing a second-line role for vedolizumab in patients unresponsive to, or intolerant of, conventional therapy.


“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.
“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.”
Dr Asit Parikh, vice-president, general medicine, Takeda.

The Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees of the FDA voted 21 out of 21 panel members for use in UC, with different votes for which conventional drugs must be tried before vedolizumab can be used.

In favour of use in CD, the panel voted 20 out 21 members, again with different votes relating to the particular level of second-line use.

In both IBD indications, the votes were fewer for recommending the use of vedolizumab in patients for whom only steroid therapy had been tried but not immunosuppressants and TNF-α antagonists.

Related news:

US FDA advisory panel backs Takeda bowel disease drug (Reuters)

Reference links:

FDA advisory committee recommends approval of Takeda’s investigational biologic vedolizumab (Takeda press release)

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