Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) today announced the launch of Entyvio(R) (generic name: vedolizumab, development code: MLN0002) for the treatment of patients with moderately to severely active ulcerative colitis (UC) in Japan.
Takeda submitted a New Drug Application to the Japanese Ministry of Health, Labour and Welfare (MHLW) in August 2017 based on the results from Study CCT-101, a Phase 3 clinical study including 292 Japanese patients with moderately to severely active UC alongside data from the global GEMINI 1 pivotal Phase 3 clinical study of vedolizumab induction and maintenance treatment involving 895 patients with moderately to severely UC.Takeda obtained the New Drug Application Approval in July 2018.
“Entyvio has been approved in more than 60 countries worldwide and has a robust clinical and real-world evidence base,” said Masato Iwasaki, Ph.D., President of the Japan Pharma Business Unit and Director of Takeda. “Takeda is pleased to provide healthcare providers and patients with an important new treatment option for ulcerative colitis and continue our mission of delivering innovative medicines for patients living with gastrointestinal diseases.”
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