Vedolizumab BLA Granted Priority Review for Ulcerative Colitis

Takeda announced that the FDA has granted Priority Review status to the Biologics License Application (BLA) for vedolizumab for the treatment of adults with moderately to severe active ulcerative colitis. Vedolizumab is a humanized monoclonal antibody that specifically antagonizes the alpha4beta7 integrin, which is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis and Crohn’s disease.

The BLA filings were supported by the GEMINI Studies, a four-study Phase 3 clinical program investigating vedolizumab for Crohn’s disease and ulcerative colitis in 2,700 patients that were intolerant or had inadequate or loss of response to at least one conventional therapy (glucocoritcoids, immunomodulators and/or tumor necrosis factor-alpha (TNF-alpha) antagonists.

The GEMINI program consists of four separate studies – a placebo-controlled induction and maintenance study in patients with UC (GEMINI I), a placebo-controlled induction and maintenance study in patients with CD (GEMINI II), a placebo-controlled induction study in patients with CD with prior TNF-alpha antagonist failure (GEMINI III) and an open-label long-term safety study in patients with either CD or UC (GEMINI LTS).

In June 2013, a BLA for vedolizumab was submitted for the treatment of adults with moderately to severe Crohn’s disease.

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