Takeda’s Entyvio Approved By FDA for Ulcerative Colitis, Crohn’s Disease

Takeda’s Entyvio Approved By FDA for Ulcerative Colitis, Crohn’s Disease
The Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis (UC) and Crohn‘s disease (CD) was recently approved by the U.S. Food and Drug Administration. The drug, which was developed by the largest pharmaceutical company in Japan, Takeda Pharmaceuticals, will now be commercially available to American healthcare providers and is recommended when one or more standard therapies don't provide an adequate response. The injection is an integrin receptor antagonist indicated for the induction and maintenance of clinical response and remission, and has been proven to improve mucosal endoscopic appearance and achieve corticosteroid-free remission in UC patients. For CD patients, on the other hand, the results may include clinical response and remission as well as corticosteroid-free remission. “We understand how a great need still exists for additional treatment options for ulcerative colitis and Crohn’s disease patients,” said Nicole Mowad-Nassar vice president of marketing for Takeda Pharmaceuticals. “We’re pleased that we were able to make Entyvio available for appropriate patients so quickly after receiving FDA approval.” Takeda performed two clinical trials to assess the safety and effectiveness of Entyvio for UC, in which the company's investigators enrolled about 900 patients who had not responded adequately to corticosteroids, immunomodulators, or tumor necrosis factor blocker medications. The evaluation of stool frequency, rectal bleeding, endoscopic findings, and a physician‘s overall assessment demonstrated that a greater percentage of participants treated with Entyvio achieved and maintained clinical response, achieved and maintained clinical remission, achieved corticosteroid-free clinical r
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