FDA approves treatment for ulcerative colitis and Crohn’s

FDA has approved vedolizumab (Entyvio, Takeda) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease.

Entyvio is approved to treat those conditions when one or more standard therapies (corticosteroids, immunomodulators, or tumor necrosis factor blocker medications) have not resulted in an adequate response.

We are very excited about the recent launch of Entyvio, a new biologic approved for treatment of patients with Crohn’s disease and ulcerative colitis,” said Caren Heller, MD, MBA, chief scientific officer, the Crohn’s & Colitis Foundation of America (CCFA). “Entyvio is a new type of biologic, with a different mechanism of action, and so should be an important new treatment option to treat these debilitating diseases.  It will be important for patients to access this new treatment and be available on formularies for the provider to be able to prescribe. CCFA encourages all formulary committees to grant access to this new medication.”

The Entyvio dose regimen is 300 mg infused intravenously over approximately 30 minutes at zero, 2, and 6 weeks, then every 8 weeks thereafter. Patients should be observed during infusion and until the infusion is complete. 

According to the Crohn’s & Colitis Foundation of America, Crohn’s disease and ulcerative colitis are both major categories of inflammatory bowel diseases (IBD). IBD affects an estimated 1.4 million Americans. These chronic diseases tend to run in families and they affect males and females equally. 

Crohn‘s disease is a chronic inflammatory condition that causes inflammation, or swelling, and irritation of any part of the digestive tract-also called the gastrointestinal (GI) tract.

Ulcerative colitis causes inflammation and ulcers in the inner lining of the large intestine, which can lead to abdominal discomfort, gastrointestinal bleeding, and diarrhea.

The safety and effectiveness of Entyvio for ulcerative colitis were established in 2 clinical trials involving approximately 900 patients who had not responded adequately to corticosteroids, immunomodulators, or tumor necrosis factor blocker medications, according to an FDA press release. 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 safety and effectiveness of Entyvio for Crohn‘s disease were established in 3 clinical trials involving approximately 1,500 patients who had not responded adequately to corticosteroids, immunomodulators, or tumor necrosis factor blocker medications. 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.

Entyvio, an integrin receptor antagonist, is a humanized monoclonal antibody that specifically binds to the alpha4beta7 integrin and blocks the interaction of alpha4beta7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue

Headache, joint pain, nausea, and fever, were the most common side effects in patients taking Entyvio. The most serious risks associated with the drug include serious infections, hypersensitivity and infusion-related reactions; and hepatotoxicity.