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Takeda's New Investigational Drug Vedolizumab is Granted Priority Review Status by U.S. Food and Drug Administration for Ulcerative Colitis
Date:9/4/2013

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The BLA filings were supported by the GEMINI™ Studies, a four-study clinical program investigating vedolizumab in 2,700 patients in nearly 40 countries, making it the largest Phase 3 clinical trial program conducted to date simultaneously evaluating both CD and UC. Enrolled patients had failed at least one conventional therapy, including glucocorticoids, immunomodulators and/or a tumor necrosis factor-alpha (TNF-alpha) antagonists. TNF-alpha antagonist and conventional therapy failure patients included those with inadequate response (primary non-responders), loss of response (secondary non-responders) or those who were intolerant.

Phase 3 study results for vedolizumab were published recently in the New England Journal of Medicine.

About the GEMINI™ Studies
Announced in early 2009, the GEMINI™ Studies is a Phase 3 program evaluating the effect of vedolizumab on clinical response and remission (along with effect on mucosal healing in UC), and long-term safety in moderately to severely active CD and UC patients who had failed at least one conventional therapy or a TNF-alpha antagonist. 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).

About Crohn's disease and ulcerative colitis
Crohn's disease (CD) and ulcerative colitis (UC) are the two most common forms of inflammatory bowel disease (IBD), which is marked by inflammation in the GI tract. CD can impact any part of the digestive tract and common symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. UC impacts the large intestine
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SOURCE Takeda Pharmaceutical Company Limited
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