Takeda Receives Positive CHMP Opinion for Entyvio® (vedolizumab) in Europe for the Treatment of Ulcerative Colitis and Crohn's Disease

Takeda Receives Positive CHMP OpinionTakeda Receives Positive CHMP Opinion for Entyvio® (vedolizumab) in Europe for the Treatment of Ulcerative Colitis and Crohn's Disease PR Newswire OSAKA, Japan, March 21, 2014 Takeda Pharmaceutical Company Limited ("Takeda") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive Opinion for Entyvio® (vedolizumab), a humanized monoclonal antibody, for the treatment of adults with moderately to severely active ulcerative colitis (UC) and adults with moderately to severely active Crohn's disease (CD) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNF- alpha) antagonist. UC and CD are the two most common types of inflammatory bowel disease (IBD), affecting more than four million people worldwide, including approximately 2.2 million Europeans. "We are very pleased by the positive Opinion issued by the CHMP for vedolizumab for ulcerative colitis and Crohn's disease, as this recognition of the clinical benefit of vedolizumab brings us closer to providing the first gut- selective biologic agent for ulcerative colitis and Crohn's disease to patients across Europe," said Trevor Smith, Head of Commercial Operations, Europe and Canada, Takeda.