FDA Approves Takeda's Colitis And Crohn's Disease Drug

The FDA has approved Takeda Pharmaceuticals’ colitis and Crohn’s disease drug, Entyvio. Entyvio, known scientifically as vedolizumab, is administered via injection. The Entyvio drug is used on patients who have not responded to standard treatments, such as corticosteroids, immunomodulators, or tumor necrosis factor blocker medications.

The drug’s approval is significant considering ulcerative colitis affects 620,000 Americans. The disease causes inflammation and ulcers in the large intestine, and is considered one of the forms of chronic inflammatory bowel disease. Patients with the disease suffer from diarrhea, gastrointestinal bleeding, and abdominal discomfort. Crohn’s disease is similar, in that it causes inflammation, swelling, and irritation of the digestive tract. More than 500,000 Americans suffer from Crohn’s disease.

Amy G. Egan, the acting deputy director of the Office of Drug Evaluation III at the FDA’s Center for Drug Evaluation and Research, released a statement about the drug approval. “Ulcerative colitis and Crohn‘s disease are debilitating diseases that impact the quality of life of those who have these conditions,” she said. “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.”

Entyvio is an integrin receptor antagonist, and it works by blocking the interaction of a certain integrin receptor with a specific protein. When the drug blocks this interaction, the migration of circulating inflammatory cells is limited. Clinical trials with Entyvio showed that patients treated with the drug have achieved a clinical response and maintained clinical remission.

Stephen B. Hanauer, MD and professor of medicine at the Digestive Health Center at Northwestern University’s Feinberg School of Medicine, was a co-investigator of the drug in clinical trials. He commented on the results, saying,  “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.”