EU approval for Takeda’s Entyvio for UC and Crohn’s disease

Takeda Pharmaceutical (TYO: 4502), Japan’s largest drugmaker has received marketing approval from the European Commission for Entyvio (vedolizumab), the first and only biologic therapy to be approved simultaneously for the treatment of adults with moderately to severely active ulcerative colitis (UC) and active Crohn's disease (CD).

UC and CD are the two most common types of inflammatory bowel disease (IBD), affecting more than four million people worldwide, including around 2.2 million in Europe, Takeda noted. Just earlier this month, the US Food and Drug Administration approved the same indications for Entyvio (The Pharma Letter May 21).

"Ulcerative colitis and Crohn's disease are serious conditions which can have a devastating impact on patients, many of whom are in early adulthood when they receive a diagnosis. As physicians, our aim is to help patients achieve and maintain remission and disease control. The approval of vedolizumab in Europe is an important step forward in the treatment of ulcerative colitis and Crohn's disease. It is the first gut-selective, biologic agent for this condition to be approved in Europe and provides us with a new therapeutic option to help us to tackle these challenging diseases," said Paul Rutgeerts, Emeritus Professor of Medicine, Catholic University of Leuven, Belgium.