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DA approves Entyvio, an injection to treat adult patients with moderate to severe ulcerative colitis and Crohn's disease.
FDA has approved Entyvio (vedolizumab), an injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease.
The safety and effectiveness of Entyvio for ulcerative colitis was established in two clinical trials involving approximately 900 patients, who had not responded adequately to corticosteroids, immunomodulators, or tumor necrosis factor blocker medications. Evaluations of patients included measures of stool frequency, rectal bleeding, endoscopic findings and a physician‘s overall assessment. Results showed that a greater percentage of participants treated with Entyvio compared to a placebo achieved and maintained clinical response, achieved and maintained clinical remission, achieved corticosteroid-free clinical remission, and as seen during endoscopy, had improved appearance of the colon. The same testing was conducted in three clinical trials with approximately 1500 patients with Crohn‘s disease. Results showed that a greater percentage of participants treated with Entyvio compared to a placebo achieved clinical response, achieved clinical remission, and achieved corticosteroid-free clinical remission.
The most common side effects in patients treated with Entyvio include headache, joint pain, nausea, and fever. The most serious risks associated with Entyvio include serious infections, hypersensitivity and infusion-related reactions, and hepatotoxicity.
Entyvio is marketed by Deerfield, Ill.-based Takeda Pharmaceuticals.