Takeda files BLA for vedolizumab for Crohn's and ulcerative colitis in USA

The US subsidiary of Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) has submitted a Biologics License Application (BLA) with the US Food and Drug Administration for vedolizumab, an investigational humanized monoclonal antibody for the treatment of adults with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC), the two most common types of inflammatory bowel disease (IBD). A similar filing was made earlier this year in Europe (The Pharma Letter March 8).

The BLA submission was supported by the Phase III clinical studies, GEMINI I, GEMINI II, GEMINI III and GEMINI LTS (Long-term Safety), which make up the GEMINI Studies, a four-study clinical program to investigate the efficacy and safety of vedolizumab on clinical response and remission in moderately to severely active CD and UC patients.

Enrolled patients had failed at least one conventional therapy, including corticosteroids, immunomodulators and/or a TNF-alpha antagonist. TNF-alpha antagonist failure patients included those with inadequate response (primary non-responders), loss of response (secondary non-responders) or those who were intolerant. Vedolizumab has been studied 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.