Takeda Pharmaceutical and subsidiary Takeda Pharmaceuticals International GmbH announced that the companies have received Marketing Authorization from the European Commission for Entyvio (vedolizumab) for ulcerative colitis (UC) and Crohn’s disease (CD) in the EU.
Entyvio is the first and currently the only EC-approved biologic therapy to simultaneously receive approval as a treatment for patients with moderately to severely active UC or CD who have had inadequate response to either a tumor necrosis factor alpha (TNF-alpha) antagonist or to standard treatment. Vedolizumab is a humanized monoclonal antibody that inhibits alpha4beta7 (α4β7) integrin to limit the ability of some white blood cells to pass through gut tissues.
Crohn’s disease and ulcerative colitis are the two leading types of inflammatory bowel disease (IBD). CD symptoms include abdominal pain, diarrhea, fever, and rectal bleeding among others. UC can cause abdominal discomfort and pus or blood in diarrhea. No cause has been discovered for either disease up to now. The diseases affect over 4 million around the world, including around 2.2 million in Europe alone.
“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.
The approval was supported by positive data from the Phase III GEMINI studies involving 2,700 patients across almost 40 countries.
Trevor Smith, head of commercial operations in Europe and Canada for Takeda, said, “In clinical trials, vedolizumab demonstrated statistically significant efficacy on a range of endpoints and was well-tolerated in trials for both UC and CD, and we are pleased that the European Commission recognizes its clinical benefit.”
The drug is now authorized for marketing in 28 EU member states along with Iceland, Norway, and Liechtenstein.