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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

for the induction of clinical response and remission in patients with moderately to severely active CD. The key primary endpoint included the proportion of patients in clinical remission with previous failure of anti-TNFalpha therapy.

GEMINI LTS is an ongoing open-label, long-term safety study of vedolizumab, and was designed to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab administration.

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

About vedolizumab
Vedolizumab is under development for the treatment of CD and UC, as a humanized monoclonal antibody that specifically antagonizes the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal cell adhesion molecule (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 CD and UC.

About Takeda Pharmaceuticals U.S.A.,
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