FDA Approves Takeda's Entyvio For Ulcerative Colitis Or Crohn's Disease

Takeda Pharmaceuticals U.S.A. announced in a press release that the Food and Drug Administration (FDA) has approved Entyvio (vedolizumab). The biologic therapy is indicated for the treatment of adults with moderate to severe active ulcerative colitis (UC) and Crohn’s disease (CD). It works to block the inflammation present in the gastrointestinal disorders.

Douglas Cole, president of Takeda Pharmaceuticals U.S.A., said, “Patients with moderately to severely active ulcerative colitis or Crohn’s disease, and the healthcare professionals who care for them, need additional new treatment options. Entyvio reflects an expansion of Takeda’s commitment to supporting patients with gastrointestinal disorders.” 

Entyvio

Entyvio (vedolizumab) is an integrin receptor antagonist. The humanized monoclonal antibody inhibits leukocyte migration and adhesion in the gastrointestinal tract. It works by binding to the alpha4beta7 integrin subunit, blocking interactions with the mucosal addressin cell adhesion molecule-1 (MAdCAM-1). Blocking this interaction slows and stops inflammation, a hallmark of UC and CD. The drug can improve endoscopic appearance of the mucosa and induce remission. Patients who have not responded to corticosteroids or tumor necrosis factor (TNF) blockers or immunomodulators have responded well to the treatment. Patients take 300 mg intravenously for 30 minutes. The following doses are spaced two weeks after the first dose, then four weeks later, followed by treatment every eight weeks. Entyvio is awaiting approval in Europe.

Entyvio Clinical Trials

The newly approved Biologics License Application (BLA) relied on Phase III trials of UC and CD patients in 40 countries. The GEMINI I, II, and III clinical trials enrolled 2,700 patients in placebo controlled studies. Investigators published results in the New England Journal of Medicine. The findings showed that patients improved in clinical response at six weeks and achieved clinical remission at 52 weeks. UC patients also showed mucosal healing compared to a placebo. CD patients were more likely to achieve remission than the placebo group. Entyvio patients were slightly more likely to have adverse reactions than the placebo group. Serious reactions were also more likely in the Entyvio group compared to the placebo patients.

In the press release published by the FDA, the agency said that health care providers should monitor patients for adverse events, especially neurological signs and symptoms. The FDA also said that it will continue to monitor adverse event reporting and it will work with Takeda on a required post-marketing study.