Takeda has been boosted by backing from advisors to the US Food and Drug Administration for its bowel disease drug vedolizumab.

A joint panel of members from the agency'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 and Crohn's disease. All 21 committee members voted that the benefits outweigh the risks to support approval for UC and 13 backed approval for UC patients who have failed steroids or immunosuppressants or TNF-alpha antagonists.

For Crohn's, 20 of the 21 panelists voted to support approval for that indication and 14 backed it for those who have failed steroids or immunosuppressants or TNF-alpha antagonists. Asit Parikh, head of general medicine at Takeda, said the firm was "very pleased with the advisory committee's recommendation", adding that "many patients lose response to currently-available treatments".

The filings are based on four studies investigating vedolizumab in 2,700 patients in nearly 40 countries, making it the largest Phase III clinical trial programme conducted to date simultaneously evaluating both UC and Crohn's patient populations. Enrolled patients had failed at least one conventional therapy.

Without asking for a vote, the FDA also requested feedback from panel members about what post-market risk mitigation strategies beyond labelling may be needed. Late last week, FDA staffers had expressed concerns about a potential link between vedolizumab and the rare brain infection progressive multifocal leukoencephalopathy.

The FDA granted vedolizumab priority review status for UC in September 2013 and a standard review for Crohn's.