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Japan : New drug approval of bile acid transporter inhibitor GOOFICE 5mg Tablet for chronic constipation was obtained in Japan.

Eisai Co., Ltd (hereinafter "Eisai"), Eisais subsidiary for gastrointestinal disease area EA Pharma Co., Ltd. (hereinafter EA Pharma) and Mochida Pharmaceutical Co., Ltd. (President: Naoyuki Mochida; Headquarters: Tokyo, Japan) (hereinafter Mochida Pharmaceutical) today announced that EA Pharma has obtained new drug approval for bile acid transporter inhibitor GOOFICE 5mg Tablet (nonproprietary name: elobixibat hydrate; development code: AJG533) (hereinafter GOOFICE Tablet) for chronic constipation (excluding structural disease-induced constipation) in Japan. GOOFICE Tablet was jointly developed by EA Pharma and Mochida Pharmaceutical.

After inclusion in the National Health Insurance drug price list, the two companies will respectively market the product under the same brand name in Japan. EA Pharma and Eisai concluded a co-promotion agreement and jointly provide proper use information of this product. GOOFICE Tablet, which EA Pharma in-licensed from Albireo AB (Headquarters: Sweden), is a once-daily, orally available constipation treatment with a novel mechanism of action. GOOFICE Tablet inhibits the bile acid transporter that regulates reabsorption of bile acids thereby increasing the flow of bile acids to the colon, which is expected to enhance natural defecation. Constipation is a very common disease, and the prevalence is particularly high in women and the elderly. In constipation, symptoms such as sensation of incomplete evacuation and hard stools appear in addition to reduction of bowel movement frequency. When such symptoms become chronic, many patients suffer from decline of QOL (quality of life).

The above new drug approval was mainly based on the results of a placebo-controlled, double-blind Phase III clinical study in patients with chronic constipation conducted in Japan. As a result of oral administration of GOOFICE Tablet or placebo once daily for 14 days, statistically significant improvements were observed in the GOOFICE Tablet group as compared to the placebo group in the primary endpoint of spontaneous bowel movement1) frequency change and also in the secondary endpoints including complete spontaneous bowel movement2) frequency change and stool consistency. There were no serious adverse events in the study.

By providing GOOFICE Tablet with its novel mechanism of action, EA Pharma, Eisai and Mochida Pharmaceutical strive to broaden treatment options for patients with chronic constipation to make a further contribution to improve patients QOL.

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Publication:Mena Report
Geographic Code:9JAPA
Date:Jan 20, 2018
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