Eisai: Drug Approval of Bile Acid Transporter Inhibitor "GOOFICE 5mg" Tablet Obtained in Japan

Jan 20, 2018 19:32 JST

Source: Eisai

For Chronic Constipation

TOKYO, Jan 20, 2018 - (JCN Newswire) - Eisai Co., Ltd., Eisai's subsidiary for gastrointestinal disease area EA Pharma Co., Ltd. and Mochida Pharmaceutical Co., Ltd 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) 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, 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 movement(1)) frequency change and also in the secondary endpoints including complete spontaneous bowel movement(2)) 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.

(1) defecation without use of laxative, enema or manual disimpaction
(2) spontaneous defecation without sensation of incomplete evacuation

Contact:

Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120

Source: Eisai
Sectors: Healthcare & Pharm

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