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Takeda's Entyvio secures Japanese approval in ulcerative colitis

Published on 02/07/18 at 11:50am

Takeda Pharmaceutical has announced that its monoclonal antibody, Entyvio (vedolizumab), has been approved for the treatment of patients with moderately to severely active ulcerative colitis (UC) in Japan. The Japanese pharmaceutical company Takeda obtained a New Drug Application Approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) following the submission of a New Drug Application bid in August 2017.

As one of the most common forms of inflammatory bowel disease (IBD), ulcerative colitis affects over 220,000 people in Japan. As such, increasingly effective treatments are much sought after. As noted by Dr Toshifumi Hibi, Director of the Centre for Advanced IBD Research and Treatment at Kitasato University Kitasato Institute Hospital: “In recent years, the number of patients with UC in Japan has been on the increase. The quality of medical treatment has improved and more treatment options are available, but many patients continue to experience difficulty in their daily lives. I believe that the addition of Entyvio to available treatment options, as a new biologic treatment for UC with a novel mechanism of action that selectively inhibits the migration of inflammatory cells in the digestive tract, represents a major step forward in the treatment of UC by bringing us closer to achieving better long-term treatment goals.”

First approved in the United States and the European Union in May 2014, Entyvio has been approved for adults with moderate to severe ulcerative colitis or Chron’s disease in more than 60 countries around the world. As reiterated by Naoyoshi Hirota, Head of the Takeda Development Center Japan: “Entyvio has been approved in more than 60 countries worldwide and has provided a major step forward in helping patients with UC achieve and maintain clinical remission. I am delighted that we are now able to offer this new treatment option to patients in Japan. The recent approval of Takeda’s New Drug Application represents a major milestone for Takeda. We aspire to bring better health and a brighter future for people worldwide through the delivery of innovative and life-changing medicines.”

Clinical trials demonstrated the effectiveness of the drug in a study of 292 Japanese patients with moderately to severely active UC. At week 60 of the trial, the primary endpoint of the maintenance phase, the clinical remission rate, was 56.1% in comparison with a rate of 31.0% for patients receiving a placebo. Furthermore treatment-emergent adverse events were generally mild-to-moderate with no clinically significant safety differences observed between the treatment groups.

Louis Goss

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