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Takeda Submits Biologics License Application for a New Investigational Drug Vedolizumab, in Moderately to Severely Active Crohn's Disease and Ulcerative Colitis in the United States
Date:6/21/2013

new treatment options is well-recognized," said William J. Sandborn, M.D., chief, division of gastroenterology & professor of medicine, University of California San Diego School of Medicine. "In clinical development, vedolizumab has demonstrated the potential to be another possible treatment option for people with moderately to severely active CD and UC."

The BLA submission was supported by the Phase 3 clinical studies, GEMINI I, GEMINI II, GEMINI III and GEMINI LTS (Long-term Safety), which make up the GEMINI Studies™, a four-study clinical program to investigate the efficacy and safety of vedolizumab on clinical response and remission in moderately to severely active CD and UC patients. Enrolled patients had failed at least one conventional therapy, including corticosteroids, immunomodulators and/or a TNF-alpha antagonist. TNF-alpha antagonist failure patients included those with inadequate response (primary nonresponders), loss of response (secondary nonresponders) or those who were intolerant. Vedolizumab has been studied 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.

GEMINI I was designed to assess the efficacy and safety of vedolizumab for inducing and maintaining clinical response and remission in patients with moderately to severely active UC in whom one prior therapy had failed. Key primary endpoints included clinical response at week six and clinical remission at week 52.

GEMINI II was designed to assess the efficacy and safety of vedolizumab for inducing and maintaining clinical response and remission in patients with moderately to severely active CD. Primary outcomes included the number of patients in clinical remission and enhanced clinical response at week six, and clinical remission at 52 weeks.

GEMINI III was designed to assess the efficacy and safety of vedolizumab
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SOURCE Takeda Pharmaceutical Company Limited
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