Takeda gets positive CHMP opinion for Entyvio for UC and Crohn’s disease

Takeda Pharmaceutical (TYO: 4502), Japan’s largest drugmaker, today received a positive opinion form the European Medicines agency’s Committee for Medicinal Products for Human Use (CHMP) for Entyvio (vedolizumab).

Entyvio, a humanized monoclonal antibody, was backed 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 tumor necrosis factor-alpha (TNF-alfa) 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.