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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

OSAKA, Japan, Aug. 21, 2013 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that results from two Phase 3 studies evaluating vedolizumab, an investigational humanized monoclonal antibody, for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD), were published in the August 22, 2013 issue of the New England Journal of Medicine. Chronic and debilitating diseases, CD and UC are the two most common types of inflammatory bowel disease (IBD) and affect more than four million people worldwide, including approximately 1.4 million Americans and 2.2 million Europeans. Vedolizumab is designed to specifically antagonize the alpha4beta7 integrin, which is expressed on a subset of circulating white blood cells that have been shown to play a role in mediating the inflammatory process in CD and UC. 

"The publication of these study findings is important since the results support the potential for vedolizumab, if approved, to help manage symptoms in some patients for whom certain previous treatments have failed," said Brian Feagan, M.D., professor of medicine, epidemiology, and biostatistics at the University of Western Ontario, Canada and GEMINI lead investigator. "The data from the GEMINI program suggest that vedolizumab may provide people living with CD and UC an additional option for inducing and maintaining clinical remission."

In the publication, study results from GEMINI I, a placebo-controlled induction and maintenance study in patients with UC, showed that vedolizumab met primary endpoints of improvement in clinical response (reduction in the Mayo Clinic score of greater than or equal to 3 points and greater than or equal to 30 percent from baseline, along with a decrease of at least 1 point on the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1) at six weeks and clinica
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SOURCE Takeda Pharmaceutical Company Limited
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