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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

DEERFIELD, Ill. and OSAKA, Japan, June 21, 2013 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that a Biologics License Application (BLA) has been submitted to the United States (U.S.) Food and Drug Administration (FDA) for vedolizumab, an investigational humanized monoclonal antibody for the treatment of adults with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC), the two most common types of inflammatory bowel disease (IBD).

"The disease burden of IBD is quite significant in the United States, especially on the many young adults living with Crohn's disease and ulcerative colitis," said Asit Parikh, M.D., Ph.D., vice president, general medicine, Takeda. "This regulatory submission marks a significant step forward for vedolizumab in the U.S., and as a company we are excited about the possibility of providing this community with a new treatment option."

More than four million people worldwide are affected by IBD, with CD affecting as many as 700,000 people and UC affecting as many as 700,000 people in the U.S. Crohn's disease and ulcerative colitis are chronic diseases that cause inflammation of the lining of the digestive tract. Inflammation caused by CD can involve all areas of the digestive tract, while UC typically impacts the colon and rectum. CD and UC can be both painful and debilitating, which may sometimes lead to serious complications. While CD and UC treatment options are available, many patients may not achieve or maintain remission of their disease.  

"CD and UC are chronic diseases that can negatively impact those who live with the associated challenges – and the need to seek
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SOURCE Takeda Pharmaceutical Company Limited
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