FDA Approves New Drug to Treat Chronic Inflammatory Diseases

Inflammatory diseases such as ulcerative colitis and Crohn's disease have no cure and some who suffer from them don't respond to existing treatments. The FDA approved a new drug on Tuesday to help over a million Americans with such diseases.

The new drug, vedolizumab, which will be sold under the brand name Entyvio, is a product of Takeda Pharmaceutical of Japan. The Food and Drug Administration made the announcement of its approval on Tuesday and hopes that it will help those who do not benefit from standard treatments for ulcerative colitis and Crohn's disease.

Approximately 620,000 Americans suffer from ulcerative colitis, which is an inflammatory bowel disease that causes long-lasting inflammation in part of the digestive tract. It usually affects the innermost lining of the large intestine and rectum. Similarly, Crohn's disease is an inflammatory bowel disease that causes inflammation of the lining of the digestive tract and spreads deep into the layers of affected bowel tissue. It affects over 500,000 Americans.

"Ulcerative colitis and Crohn's disease are debilitating diseases that impact the quality of life of those who have these conditions," said Amy G. Egan, M.D., M.P.H., of the FDA's Center for Drug Evaluation and Research, in this FDA news release. "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."

The new drug, Entyvio, is an integrin receptor antagonist, which are proteins that are expressed on the surface of certain cells. In this case, Entyvio blocks the interaction of an integrin receptor that is expressed on circulating inflammatory cells. As a result, it inhibits the circulation of the inflammatory cells and helps rid inflammation.

Entyvio was tested in clinical trials for both the inflammatory diseases in question. In two clinical trials involving 900 patients who did not respond to standard treatments for ulcerative colitis, the drug helped patients achieve and maintain clinical remission, corticosteroid-free clinical remission, and improved appearance of the colon.

In three clinical trials involving 1,500 patients suffering from Crohn's disease, Entyvio revealed a high percentage of clinical response, clinical remission, and corticosteroid-free clinical remission. For both trials, the drug show significant strides compared to patients in the placebo groups.