Takeda Pharmaceutical Company has submitted marketing authorisation application (MAA) seeking approval from the European Medicines Agency (EMA) for its investigational, gut-selective humanized monoclonal antibody for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD).
The monoclonal antibody, Vedolizumab, antagonizes alpha4beta7 (-47) integrin expressed on a subset of circulating white blood cells and treat most common types of inflammatory bowel diseases (IBD) such as UC and CD.
UC and CD, which are chronic debilitating diseases, affect young people in the prime of their lives and need new treatments, claims the company.
The MAA included positive Phase 3 clinical studies including GEMINI I, GEMINI II, GEMINI III and GEMINI LTS (Long-term Safety), which are part of the four-study clinical research program GEMINI Studies.
The program was designed to investigate the efficacy and safety of vedolizumab on clinical response and remission in moderately to severely active CD and UC patients, who had failed at least one conventional or anti-TNF- therapy.
Takeda Pharmaceutical Company general medicine vice president Asit Parikh said, "We are encouraged by the findings of GEMINI, the vedolizumab Phase 3 clinical development program, which studied approximately 3,000 patients in nearly 40 countries, making it the largest IBD clinical trial program conducted to date."
Catholic University of Leuven medicine professor Paul Rutgeerts said, "With a targeted mechanism of action, vedolizumab has clinical promise as a potential treatment option for people with moderate to severely active CD and UC."
