FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

FDA Advisors Recommend Approval of Takeda’s Biologic Vedolizumab

Dec. 11, 2013
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A joint panel of FDA advisors has recommended approval of Takeda’s BLA for humanized monoclonal antibody vedolizumab for two indications: as a treatment for adults with aggressive forms of ulcerative colitis (UC) and for Crohn’s disease.

Takeda’s application, submitted in June, was based on four clinical studies involving 2,700 patients in almost 40 countries and received priority review for ulcerative colitis and standard review for Crohn’s disease in September.

The breakdown of the voting by the combined FDA Gastrointestinal Drugs Advisory Committee and FDA Drug Safety and Risk Management Advisory Committee is as follows:

  • Thirteen of 21 panelists voted to approve the drug for UC patients who have not done well with steroids, immunosuppressants or TNF-α antagonists;
  • Eight voted to approve the drug for UC patients who have not done well with immunosuppressants or TNF-α antagonists;
  • Fourteen voted to approve vedolizumab for Crohn’s patients who have not had success with steroids, immunosuppressants or TNF-α antagonists; and
  • Six voted to approve vedolizumab for Crohn’s patients who have not seen success with immunosuppressants or TNF-α antagonists.

The joint panel was unanimous in support of the sponsor’s characterization of the drug’s safety.

Vedolizumab’s PDUFA date for ulcerative colitis is Feb. 18, 2014, while a decision on Crohn’s disease is expected on June 18. The agency is also working with Takeda on an appropriate REMS strategy for the drug. — Lena Freund