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Takeda scores Japanese Entyvio approval in Crohn's disease

Published on 22/05/19 at 10:22am

Takeda has announced that Japan’s drug regulator, the Ministry of Health, Labour and Welfare (MHLW), has approved Entyvio (vedolizumab) in the treatment of moderately to severely active Crohn’s disease (CD).

The gut-selective biologic drug was originally launched in the country in November 2018, following approval for moderate to severe ulcerative colitis in July. This most recent approval also follows the reveal of new Phase 3 data for the drug which demonstrated its superiority over AbbVie’s blockbuster Humira in achieving remission in moderately to severely active ulcerative colitis.

The MHLW’s decision was based on data illustrating that 41.7% of Entyvio patients achieved remission after 60 weeks of treatment, compared to 16.7% of placebo patients. The Entyvio group also showed superior improvement in CDAI-100 scores compared to placebo, but this did not reach statistical significance.

“Crohn's disease is an inflammatory bowel disease along with ulcerative colitis. The number of patients with Crohn's disease in Japan is rapidly increasing, and many patients experience difficulties in their daily lives from this chronic disease,” remarked Dr Takanori Kanai, Professor of Gastroenterology and Hepatology at Keio University. “Entyvio is a biologic medicine with a new mechanism of action that regulates the immune response selectively in the gut and was approved last year in Japan as a new treatment option for ulcerative colitis. This approval means there is now another option that can help contribute to the solution of unmet needs in the treatment of Crohn's disease.”

Naoyoshi Hirota, Director of the Japan Development Center, also commented: “Entyvio has been approved in more than 60 countries worldwide and has been contributing to the induction and maintenance of clinical remission of patients with ulcerative colitis since last year in Japan. I am proud that we can now offer Entyvio as a treatment option for patients with Crohn's disease in Japan. The addition of this indication is an important milestone for Takeda. We will continue our efforts to improve the lives of patients through innovative medicines.”

Matt Fellows

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