Albireo Pharma Inc. said EA Pharma Co. Ltd. filed a new drug application to the Japanese Pharmaceuticals and Medical Devices Agency for elobixibat, a chronic constipation drug.
EA Pharma holds the exclusive license for elobixibat as gastrointestinal disorder treatment in Japan and other select countries in Asia.
If approved, EA Pharma will co-market the drug in Japan with Mochida Pharmaceutical Co. Ltd.
Elobixibat is an orally available ileal bile acid transporter inhibitor that helps improve secretion and motility in the large bowel. In a phase 3 clinical trial, the drug met the primary endpoint, change in the number of weekly spontaneous bowel movements from baseline to the first treatment week compared with placebo, with high statistical significance.