Takeda starts phase-3 trials of vedolizumab

Company seeks approval of drug in patients with ulcerative colitis, Crohn's disease

OSAKA, Japan — Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

Takeda announced the start of two phase-3 trials of MLN0002 (vedolizumab) in patients with severe ulcerative colitis and Crohn's disease. The trials are designed to find out the efficacy, safety and effects on the body of the drug, particularly to see if patients show a response after 10 weeks of treatment and disease remission after 60 weeks.

"Many patients suffering from ulcerative colitis and Crohn's disease are eagerly awaiting new treatment options," Takeda VP general medicine Asit Parikh said. "We are striving to accelerate the development of this drug to deliver this effective and highly anticipated treatment option for patients in Japan as soon as possible."

Takeda submitted a regulatory approval application to the Food and Drug Administration for the drug in June 2013.

 

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