Takeda files for vedolizumab approval in Japan

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) has submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan for the investigational humanized monoclonal antibody vedolizumab (development code: MLN0002) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

The NDA filing included data from Study CCT-101, a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III study investigating the efficacy, safety and pharmacokinetics of vedolizumab induction and maintenance treatment involving 292 Japanese patients with moderate or severe UC. Results from Study CCT-101 will be presented at scientific meeting in the future. The NDA filing also included data from the international, randomized, double blind, placebo-controlled GEMINI I pivotal Phase III study of vedolizumab induction and maintenance treatment involving 895 patients with moderate to severe UC.

“UC is a chronic, progressive inflammatory disease of the large intestine, which typically affects young adults. The disease has a high impact on their quality of life with symptoms including diarrhea, rectal bleeding, incontinence and abdominal pain,” said Toshiro Heya, head of Takeda Development Center Japan. “Through this submission, we may provide an alternative treatment option to the increasing number of people with UC in Japan.”