FDA Approves Entyvio for Colitis Crohn’s Disease

In giving the green light to Japan-based Takeda Pharmaceuticals’ Entyvio (vedolizumab) injection, the Food and Drug Administration (FDA) is offering patients with ulcerative colitis and Crohn's disease a new treatment option, when one or more standard therapies (corticosteroids, immunomodulators, or tumor necrosis factor blocker medications) have not done enough to treat their symptoms.

Ulcerative colitis is a chronic disease affecting about 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, or swelling, and irritation of any part of the digestive tract, also known as the gastrointestinal (GI) tract. More than a half million Americans have been diagnosed with Crohn‘s disease.

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Drug Helps Control Symptoms

Amy G. Egan, M.D., M.P.H., acting deputy director of the Office of Drug Evaluation III in the FDA‘s Center for Drug Evaluation and Research, said in a press statement, “Ulcerative colitis and Crohn‘s disease are debilitating diseases that impact the quality of life of those who have these conditions.”

Egan continued, “Although there is no cure for these conditions, today‘s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy to help control their symptoms.”

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How Integrin Receptor Antagonists Work

Entyvio is an integrin receptor antagonist. Integrin receptors are proteins expressed on the surface of certain cells, which function as bridges for cell-cell interactions. Entyvio 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), and thereby blocks the migration of those circulating inflammatory cells across those blood vessels and into areas of inflammation in the gastrointestinal tract.

Entyvio Can Help Patients Manage Disease

Entyvio for ulcerative colitis was studied in two clinical trials involving approximately 900 patients. Patients were evaluated for measures of stool frequency, rectal bleeding, endoscopic findings, and a physician’s overall assessment. 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 an improved appearance of the colon.

When Entyvio for Crohn’s disease was studied in three clinical trials involving approximately 1,500 patients, a greater percentage of participants treated with Entyvio compared to a placebo achieved clinical response, clinical remission, and corticosteroid-free clinical remission.

Stephen B. Hanauer, M.D., professor of medicine and co-director of the Digestive Health Center, at Northwestern University Feinberg School of Medicine, and co-investigator in the vedolizumab clinical trials, told Healthline that the FDA approval of Entyvio is groundbreaking in that it is a new class of biologic agents for treating ulcerative colitis.

Hanauer went on to say there are a large number of biologic therapies, including Remicade, Humira, Cimzia, and Simponi, which block the chemical (protein) TNF, which stands for tumor necrosis factor.

“Entyvio blocks a receptor that prevents inflammatory cells from getting into the tissues. It’s been effective now in treating patients with ulcerative colitis and Crohn’s disease. It’s a totally different class of agents than what we’ve had. It will help patients whether or not they had received other biologic therapies. It’s been effective in people who’ve never seen other biologics, and also it’s been effective in patients who have not responded to the anti-TNF class,” said Hanauer.

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Common Side Effects and Risks

Headache, joint pain, nausea, and fever were among the most common side effects reported. The most serious risks associated with Entyvio include serious infections, hypersensitivity and 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 only occurs in patients whose immune systems are compromised. There were no cases of PML identified among Entyvio clinical trial participants.

In its news release, the FDA advised healthcare professionals to closely monitor patients on vedolizumab for new or worsening neurologic symptoms, noting that it plans postmarketing surveillance and adverse event reporting.

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