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 vedolizumab’s effectiveness in 895 patients with moderate to severe ulcerative colitis.
“We aim to provide life-changing therapeutics for individuals suffering from GI [gastrointestinal] diseases by focusing on underlying disease drivers and leveraging diverse modalities” of treatment, said Dr. Asit Parikh, head of Takeda’s gastroenterology therapy unit.
Ulcerative colitis patients have a high level of inflammation-generating white blood cells in their gut. Vedolizumab reduces the inflammation by preventing the cells from getting to the inflamed tissue.
More than 60 countries have approved vedolizumab, including the United States and the European Union. The U.S. Food and Drug Administration authorized it in 2014 as a treatment for adults with moderate to severe ulcerative colitis or Crohn’s disease. The approval covers patients who fail to respond to, have developed resistance to, or are intolerant of standard therapy or a TNFα antagonist.