Eisai Decides Additional Study for Pariet® for New Indication of Non-Erosive Gastro-Esophageal Reflux Disease in Japan
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) submitted an application in Japan for a new indication of non-erosive gastro-esophageal reflux disease for Pariet®, a proton pump inhibitor, on March 27, 2006. As a result of consultation with the Pharmaceuticals and Medical Devices Agency, Eisai has made a decision to conduct additional study which will support the submitted data from the original application. Therefore, Eisai will withdraw the application at this time, and aims to resubmit it in FY2008.
Pariet® was launched first in Japan in 1997. Following that, the product began to be marketed in the Europe in 1998 and in the U.S. (by the brand name AcipHex®) in 1999. Currently, Pariet® is approved in 97 countries around the world.
According to the clinical studies, Pariet® has shown a rapid onset of action, a stable inhibitory effect on acid secretion with the approved indication in Japan including stomach ulcers, duodenal ulcers, gastro-esophageal reflux disease, and as a supplemental treatment for Helicobacter pylori eradication in gastric/duodenal ulcers.
Corporate Communications Department
Eisai Co., Ltd.