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Takeda Announces Extension of FDA PDUFA Action Date for Vedolizumab for Ulcerative Colitis
Date:12/24/2013

or both proposed UC and CD indications. The outcome of the advisory committee meeting is non-binding and will be taken into consideration by the FDA when making its decision on Takeda's BLAs for vedolizumab.

About ulcerative colitis and Crohn's disease
Ulcerative colitis (UC) and Crohn's disease (CD) are the two most common forms of inflammatory bowel disease (IBD), which is marked by inflammation in the GI tract. UC impacts the large intestine only, which includes the colon and the rectum. The most common symptoms of UC include abdominal discomfort and blood or pus in diarrhea. CD can impact any part of the digestive tract and common symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. There is no known cause for UC or CD, although many researchers believe that the interaction between genes, the body's immune system, and environmental factors may play a role. The aim of UC and CD treatments is to induce and maintain remission, or achieve extended periods of time when patients do not experience symptoms.

About vedolizumab
Vedolizumab, under development for the treatment of UC and CD, is a humanized monoclonal antibody that specifically antagonizes the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1). MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. The alpha4beta7 integrin is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in UC and CD. By inhibiting alpha4beta7, vedolizumab may limit the ability of certain lymphocytes to infiltrate gut tissues.

About Takeda Pharmaceuticals U.S.A., Inc.
Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the
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SOURCE Takeda Pharmaceutical Company Limited
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