On December 9, all 21 members of the Food and Drug Administration (FDA) Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committee voted in favor of vedolizumab for treatment of moderate to severe ulcerative colitis in adults. The committee determined that, that based on currently available efficacy and safety data, the benefits outweigh the potential risks.
Ulcerative colitis and Crohn’s disease are the two most common types of inflammatory bowel disease; the two diseases affect approximately 1.4 million Americans. The committee’s decision does not guarantee that the drug will obtain FDA approval; however, the agency usually concurs with advisory committee’s decisions. More than half (13) of the committee members supported approval vedolizumab for ulcerative colitis patients who have failed steroids, immunosuppressants, TNF-alpha antagonists; eight committee members supported approval for ulcerative colitis patients who have failed immunosuppressants or TNF-alpha antagonists. All but one committee member supported approval of the drug for Crohn’s disease; 14 committee members supported approval for Crohn’s disease patients who failed steroids, immunosuppressants, or TNF-alpha antagonists, and six supported approval for Crohn’s disease patients who have failed immunosuppressants or TNF-alpha antagonists.
In September 2013, the FDA granted vedolizumab Priority Review status for treatment of ulcerative colitis and standard review for the treatment of Crohn’s disease. The FDA grants Priority Review status for investigational drugs that treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.
Vedolizumab was evaluated by the GEMINI™ Studies, which was a four-study clinical program that examined the drug in 2,700 patients in nearly 40 different nations; thus, it was the largest Phase 3 clinical trial program conducted to date simultaneously evaluating patients with ulcerative colitis or Crohn’s disease. The subjects had failed at least one conventional therapy, including glucocorticoids, immunomodulators and/or a tumor necrosis factor-alpha antagonist. TNF-alpha antagonist; in addition, the study comprised conventional therapy failure patients who had an inadequate response loss of response, or patients who were intolerant.
There is no known cause for Crohn’s disease or ulcerative colitis; however, both diseases our thought to be due to an interaction between genes, the immune system, and environmental factors. The treatment goal for both diseases is to induce and maintain disease remission; if sustained remission is not achieved, the treatment goal is to at least achieve extended periods of time when patients are symptoms-free. Bothe ulcerative colitis and Crohn's disease involve inflammation in the intestinal tract. Ulcerative colitis involves only the large intestine only, which includes the colon and the rectum. The most common symptoms of ulcerative colitis are abdominal discomfort and blood or pus in diarrhea. Crohn’s disease can involve any part of the digestive tract; common symptoms are abdominal pain, diarrhea, rectal bleeding, weight loss, and fever.