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Data Published in the New England Journal of Medicine for Vedolizumab, an Investigational New Drug from Takeda for Moderately to Severely Active Ulcerative Colitis and Crohn's Disease
Date:8/21/2013

l remission (Mayo score of 2 or lower and no subscore higher than 1) at 52 weeks. In addition, a significantly greater proportion of patients receiving vedolizumab achieved mucosal healing (Mayo endoscopic subscore of 0 or 1) at six and 52 weeks, and glucocorticoid-free remission at 52 weeks, compared with placebo. Discussed in a separate publication, results from GEMINI II, a placebo-controlled induction and maintenance study in patients with CD, showed that vedolizumab demonstrated statistically significant improvement in the primary endpoint of clinical remission (Crohn's disease activity index [CDAI] score less than or equal to 150 points) at six weeks and at 52 weeks compared to placebo. At six weeks, no significant difference was observed in the co-primary endpoint of CDAI-100 response (greater than or equal to 100-point decrease in the CDAI score) between the vedolizumab and placebo groups. A significantly greater proportion of patients showed CDAI-100 response and glucocorticoid-free remission at 52 weeks.

GEMINI I and GEMINI II are part of the four-study GEMINI Studies™, studying 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) antagonist. TNF-alpha antagonist failure patients included those with inadequate response (primary non-responders), loss of response (secondary non-responders) or those who were intolerant.

"These clinical studies suggest that vedolizumab may have the potential to maintain clinical remission in the appropriate patients," said Asit Parikh, M.D., Ph.D., vice president, general medicine, Takeda. "Takeda has a strong legacy of researching and treating GI disorders globally, and vedolizumab represents our fo
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SOURCE Takeda Pharmaceutical Company Limited
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