Updated on 5 September 2013
CD and UC are the two most common types of inflammatory bowel disease (IBD), and can be both painful and debilitating, sometimes leading to serious complications. 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 2,700 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 (primary non-responders), loss of response (secondary non-responders) or those who were intolerant.
Phase III study results for vedolizumab were published recently in the New England Journal of Medicine.