announced that FDA has granted Priority Review status for the Biologics License Application (BLA) for its investigational drug vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC). A BLA was submitted in June 2013 seeking approval for vedolizumab for the treatment of adults with moderately to severely active Crohn's disease (CD) or UC.
CD and UC are the two most common types of inflammatory bowel disease. While CD and UC treatment options are available, many patients may not achieve or maintain remission of their disease.
The BLA filings were supported by the GEMINI Studies, a four-study clinical program investigating vedolizumab in 2700 patients in nearly 40 countries, making it the largest Phase III clinical trial program conducted to date simultaneously evaluating both CD and UC. Enrolled patients had failed at least one conventional therapy, including glucocorticoids, immunomodulators, and/or a tumor necrosis factor-alpha (TNF-alpha) antagonists. TNF-alpha antagonist and conventional therapy failure patients included those with inadequate response, loss of response, or those who were intolerant.
Phase III study results for vedolizumab were published recently in the New England Journal of Medicine.