World’s First Bile Acid Transporter Inhibitor “GOOFICE® 5mg Tablet” Launched in Japan
Eisai Co., Ltd. (CEO: Haruo Naito; Headquarters: Tokyo, Japan) (hereinafter "Eisai"), Eisai‘s subsidiary for gastrointestinal diseases EA Pharma Co., Ltd. (President & CEO: Yuji Matsue; Headquarters: Tokyo, Japan) (hereinafter "EA Pharma") and Mochida Pharmaceutical Co., Ltd. (President: Naoyuki Mochida; Headquarters: Tokyo, Japan) (hereinafter "Mochida") today announced that the bile acid transporter inhibitor "GOOFICE® 5mg Tablet" (nonproprietary name: elobixibat hydrate; development code: AJG533) (hereinafter "GOOFICE® Tablet") was listed in Japan’s National Health Insurance Drug Price List as of April 18, 2018, and EA Pharma and Mochida launched the product onto Japan‘s market today.
GOOFICE® Tablet, which EA Pharma in-licensed from Albireo AB (Sweden), is a once-daily, orally available constipation treatment with a novel action mechanism. GOOFICE® Tablet inhibits the bile acid transporter that regulates reabsorption of bile acids thereby increasing the flow of bile acids to the colon. The dual action of moisture secretion and bowel movement promotion is expected to enhance natural defecation. GOOFICE® Tablet is the first ileal bile acid transporter inhibitor approved anywhere in the world.
Constipation is a very common disease. The prevalence is high in young women and both elderly men and women. In Japan, the number of patients with subjective symptoms of constipation is estimated to be about 4.5 million. 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 a decline in QOL (quality of life). In a placebo-controlled, double-blind Phase 3 clinical study conducted in Japan, which was the basis for marketing approval, there were statistically significant improvements observed in changes in spontaneous bowel movement (primary endpoint), complete spontaneous bowel movement (secondary endpoint), time to first spontaneous bowel movement, stool consistency and other parameters for the GOOFICE® Tablet-treated group compared to the placebo group. No serious adverse events were observed.
GOOFICE® Tablet was jointly developed by EA Pharma and Mochida. EA Pharma and Mochida will distribute the product under the same brand name, respectively. EA Pharma and Eisai have signed a co-promotion agreement and will jointly provide information for proper use of the product.
By providing GOOFICE® Tablet with its novel mechanism of action, EA Pharma, Eisai and Mochida strive to broaden treatment options for patients with chronic constipation to make a further contribution to improve patients’ QOL.