Entvio, a Takeda Monoclonal Drug, has been approved by the FDA

Takeda announced on May 20 that the monoclonal antibody Entyvio (vedolizumab) has been approved by the FDA for moderate to severe active colitis (UC) and Crohn's disease (CD) Treatment of adult patients. The FDA granted vedolizumab priority for review in September 2013.

In addition, vedolizumab received a positive opinion from the European Medicines Agency (EMA) Committee on Medicinal Products for Human Use (CHMP) approval in March 2014.

The submission of the Vedolizumab Bio-Product Licensing Application (BLA) is based on summary data from the GEMINI project, which includes four phase III studies, the largest phase III clinical trial ever conducted in CD and UC patients. Evaluation of vedolizumab for the treatment of patients with moderate to severe active Crohn's disease and ulcerative colitis who have been treated with at least one conventional therapy or with TNF-&alPHa; antagonist failure, clinical response, clinical remission, long-term safety Impact.

Vedolizumab is a fully humanized monoclonal antibody that specifically antagonizes the binding of &alPHa; 4β7 integrin, inhibits &alPHa; 4β7 integrin on the intestinal mucosal cell adhesion molecule MAdCAM-1. MAdCAM-1 is selectively expressed in gastrointestinal blood vessels and lymph nodes. The α4β7 integrin is expressed in a group of circulating leukocytes that have been shown to play an important role in mediating inflammation in CD and UC diseases.