Takeda files vedolizumab at FDA for Crohns disease and Ulcerative Colitis

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., announced that a Biologics License Application (BLA) has been submitted to the FDA 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).

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 nonresponders), loss of response (secondary nonresponders) or those who were intolerant.