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FDA Approves Entyvio (Vedolizumab) to Treat Ulcerative Colitis and Crohn’s Disease
The FDA has given the green light to Entyvio (vedolizumab, Takeda Pharmaceuticals America, Inc.) injection for the treatment of adults with moderate-to-severe ulcerative colitis and adults with moderate-to-severe Crohn’s disease.
The drug is approved to treat those conditions when one or more standard therapies (i.e., corticosteroids, immunomodulators, or tumor necrosis factor [TNF] blockers) have not resulted in an adequate response.
Ulcerative colitis is a chronic disease that affects approximately 620,000 Americans. It causes inflammation and ulcers in the inner lining of the large intestine and is one of two main forms of chronic inflammatory bowel disease. The inflammation can lead to abdominal discomfort, gastrointestinal bleeding, and diarrhea.
Crohn’s disease is a chronic inflammatory condition that causes inflammation and irritation in the gastrointestinal (GI) tract. More than 500,000 Americans have been diagnosed with the disorder.
The safety and effectiveness of vedolizumab in the treatment of ulcerative colitis were established in two clinical trials involving approximately 900 patients who had not responded adequately to corticosteroids, immunomodulators, or TNF blockers. Evaluations included measures of stool frequency, rectal bleeding, endoscopic findings, and the physician’s overall assessment.
The results of these studies showed that a greater percentage of participants treated with vedolizumab compared with placebo achieved and maintained a clinical response, achieved and maintained clinical remission, achieved corticosteroid-free clinical remission, and had an improved appearance of the colon, as seen during endoscopy.
The safety and effectiveness of vedolizumab in the treatment of Crohn’s disease were established in three clinical trials involving approximately 1,500 patients who had not responded adequately to corticosteroids, immunomodulators, or TNF blockers. The results showed that a greater percentage of participants treated with vedolizumab compared with placebo achieved a clinical response, clinical remission, and corticosteroid-free clinical remission.
Vedolizumab is an integrin receptor antagonist. Integrin receptors are proteins expressed on the surface of certain cells. These proteins function as bridges for cell–cell interactions. Vedolizumab blocks the interaction of a specific integrin receptor (expressed on circulating inflammatory cells) with a specific protein (expressed on cells in the interior wall of blood vessels), thereby blocking the migration of those circulating inflammatory cells across those blood vessels and into areas of inflammation in the GI tract.
The most common adverse effects in patients treated with vedolizumab include headache, joint pain, nausea, and fever. The most serious risks associated with vedolizumab include serious infections, hypersensitivity, infusion-related reactions, and hepatotoxicity.
Another type of integrin receptor antagonist has been associated with progressive multifocal leukoencephalopathy (PML), a rare and often fatal opportunistic infection of the central nervous system. PML is caused by a virus and typically occurs only in patients whose immune systems are compromised. No cases of PML were identified among participants in clinical trials of vedolizumab.