FDA approve Entyvio for Ulcerative Colitis and Crohn's Disease - Takeda

Takeda Pharmaceuticals has announced that the FDA simultaneously approved Entyvio (vedolizumab), for the treatment of adults with moderately to severely active Ulcerative Colitis (UC) and Crohn's Disease (CD). The filing was supported by the largest Phase III clinical trial program conducted to date simultaneously evaluating both UC and CD patient populations in four clinical studies involving 2,700 patients in nearly 40 countries.

Three of these studies were randomized, double-blind, placebo-controlled trials � GEMINI I (UC Trials I and II), GEMINI II (CD Trials I and III) and GEMINI III (CD Trial II). GEMINI I, II and III evaluated adult patients with moderately to severely active UC or CD who had an inadequate response or intolerance to immunomodulator therapy; inadequate response, loss of response, or intolerance to a TNF blocker; or were corticosteroid dependent or had an inadequate response or intolerance to corticosteroids. Adverse reactions were reported in 52 percent of patients treated with Entyvio and 45 percent of patients treated with placebo (UC Trials I and II: 49 percent with Entyvio and 37 percent with placebo; CD Trials I and III: 55 percent with Entyvio and 47 percent with placebo).