FDA approves vedolizumab for ulcerative colitis and Crohn's

By Reuters Staff

(Reuters) - U.S. health regulators on Tuesday approved a drug from Japan's Takeda Pharmaceutical Co Ltd to treat the chronic debilitating inflammatory diseases ulcerative colitis and Crohn's disease.

The Food and Drug Administration said it had approved vedolizumab, which will be sold under the brand name Entyvio, for patients who failed to gain adequate relief from one or more current standard treatments.

"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," Amy Egan, acting deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said in a statement.

The injected biotech drug is an integrin receptor agonist that works by blocking circulating inflammatory cells from reaching areas of inflammation in the digestive tract.

Ulcerative colitis, which affects about 620,000 Americans, causes inflammation and ulcers in the inner lining of the large intestine that can lead to abdominal pain, gastrointestinal bleeding, and diarrhea.

Crohn's, affecting more than half a million Americans, can cause inflammation, swelling, and irritation of any part of the digestive tract.

The most serious risks associated with Entyvio include serious infections, hypersensitivity and infusion-related reactions and liver toxicity, the FDA said.

(c) Copyright Thomson Reuters 2014. Click For Restrictions - http://about.reuters.com/fulllegal.asp