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Takeda Announces Primary Endpoints Met for Pivotal Phase 3 Trial of Vedolizumab in Patients with Moderately to Severely Active Ulcerative Colitis Who Have Failed at Least One Conventional Therapy

Update: Entyvio (vedolizumab) Now FDA Approved - May 19, 2014

GEMINI I Trial Met Primary Endpoints of Improvements in Clinical Response in Induction and Clinical Remission in Maintenance

OSAKA, Japan--(BUSINESS WIRE)--Feb 20, 2012 - Takeda Pharmaceutical Company Limited (TSE:4502) today announced top-line results from the international, randomized, placebo-controlled, double-blind GEMINI I pivotal Phase 3 trial evaluating vedolizumab in 895 patients with moderately to severely active ulcerative colitis who have failed at least one conventional therapy, including TNFα antagonists. Patients received a year of vedolizumab (MLN0002) or placebo treatment, starting with six weeks of induction therapy. Both phases of the trial met their primary endpoints, providing statistically significant improvements in clinical response in the induction phase and clinical remission in the maintenance phase.

The most common adverse events (>10 percent) reported in both the vedolizumab arm and the placebo arm were colitis, headache and nasopharyngitis.

“We are very pleased with the outcomes of this pivotal trial, and the potential that vedolizumab holds for patients with this debilitating disease,” said Tadataka Yamada, M.D., Chief Medical and Scientific Officer, Takeda. “We thank the patients and investigators for their engagement and participation in this clinical evaluation of vedolizumab.”

Detailed results will be presented at an upcoming medical congress.


The randomized, placebo-controlled, double-blind GEMINI I Phase 3 study enrolled 895 patients with moderately to severely active ulcerative colitis who have failed at least one conventional therapy, at more than 210 sites in more than 34 countries.

About Vedolizumab

Vedolizumab is an investigational humanized monoclonal antibody against α4β7 integrin, which is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis and Crohn's disease.

About Ulcerative Colitis

Ulcerative colitis is a chronic relapsing-remitting condition, caused by an overactive inflammatory response in the gastrointestinal tract. Common symptoms include diarrhea, rectal bleeding, incontinence, abdominal pain, fever, malaise and weight loss.

About Takeda

Located in Osaka, Japan, Takeda Pharmaceutical Company Limited (TSE:4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website,

Contact: Takeda Pharmaceutical Company Limited
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Posted: February 2012