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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

cus on and commitment to patient communities."

Takeda submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in June, 2013, as well as a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in March, 2013, seeking approval for vedolizumab for the treatment of adults with moderately to severely active CD and UC.

CD and UC are chronic diseases of the digestive tract. CD can involve all areas of the digestive tract, while UC typically affects the colon and rectum. CD and UC can be both painful and debilitating and patients may have bleeding, diarrhea, fatigue, weight loss and anemia, among other symptoms. Both diseases involve excess inflammation in the gut tissue that occurs when white blood cells infiltrate the gastrointestinal tract and may lead to serious complications. 

"Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis"
The publication, titled "Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis," discusses findings from GEMINI I, a Phase 3, randomized, double-blind, placebo-controlled induction and maintenance study designed to assess the efficacy and safety of vedolizumab on clinical response and remission in patients with moderately to severely active UC, in whom one prior therapy had failed. In the induction phase, the primary endpoint was improvement in clinical response at six weeks. Secondary endpoints were to determine the effect of vedolizumab induction treatment on clinical remission and mucosal healing at six weeks. The intent-to-treat (ITT) population comprised 374 patients, with an additional 521 patients receiving open-label vedolizumab. Of the 374, 225 received vedolizumab 300 mg IV and 149 received placebo on days 1 and 15. Approximately 40 percent of the ITT population had prior anti-TNF failure. At week six, 47.1 percent of patients receiving vedolizumab achieved clinical response compared to 2
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SOURCE Takeda Pharmaceutical Company Limited
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