Takeda Pharmaceutical Company announced that it has submitted a New Drug Application to the Ministry of Health, Labour and Welfare in Japan for the investigational humanized monoclonal antibody vedolizumab (generic name, 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 3 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 future1. The NDA filing also included data from the international, randomized, double blind, placebo-controlled GEMINI I pivotal Phase 3 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.”
“We aim to provide life changing therapeutics for individuals suffering from GI diseases by focusing on underlying disease drivers and leveraging diverse modalities,” said Dr. Asit Parikh, head of Gastroenterology Therapeutic Area.
Vedolizumab was approved in the European Union and the U.S. in May 2014 for the treatment of adults with moderately to severely active UC or Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Currently, vedolizumab is approved in more than 60 countries with over 113,000 patient years of exposure to date.3
Filed Under: Drug Discovery
