Takeda Asks Japanese Regulators to Approve Vedolizumab as an Ulcerative Colitis Treatment

Takeda Asks Japanese Regulators to Approve Vedolizumab as an Ulcerative Colitis Treatment
Takeda Pharmaceutical Company has submitted a new drug application to Japanese regulators for vedolizumab (MLN0002) as a treatment for adults with moderate to severe ulcerative colitis. Ulcerative colitis "is a chronic, progressive inflammatory disease of the large intestine, which typically affects young adults," Toshiro Heya, head of Takeda Development Center Japan, said in a press release. "The disease has a high impact on their quality of life, with symptoms including diarrhea, rectal bleeding, incontinence and abdominal pain. Through this submission [new drug application], we may provide an alternative treatment option to the increasing number of people with UC in Japan.” In Japan, the agency that approves new drugs is the Ministry of Health, Labor and Welfare. Two Phase 3 clinical trials showed vedolizumab to be effective against ulcerative colitis. CCT-101 (NCT02039505) was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. It looked at the effectiveness, safety, and pharmacokinetics of vedolizumab in 292 Japanese patients with moderate or severe ulcerative colitis. Pharmacokinetics refers to the body's effect on a drug. Takeda plans to present the trial results at a conference. GEMINI I (NCT00783718) was an international, randomized, double blind, placebo-controlled trial that assessed ved
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