Japanese marketing clearance for Entyvio against ulcerative colitis

2 July 2018

The Japanese medicines regulator has approved Tokyo-based Takeda Pharmaceutical’s (TSE: 4502) application to market Entyvio (vedolizumab) in ulcerative colitis (UC).

The application, which was based on results from the Phase III CCT-101 and GEMINI 1 studies, was filed with the Ministry of Health, Labor and Welfare (MHLW) in August last year.

The approval in Takeda’s home country comes after European Union and US approvals in May 2014, where the therapy has been used to treat patients with UC or Crohn’s disease for whom conventional therapy or a TNFα blocker has not worked.

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