Eisai Submits Application for Additional Indication of its Proton Pump Inhibitor PARIET® for Non-erosive GERD in Japan
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that it had submitted an application for additional indication of its proton pump inhibitor PARIET® (generic name: rabeprazole sodium) for non-erosive gastro-esophageal reflux disease (GERD) in Japan. The application for this additional indication was originally submitted on March 27, 2006 and was withdrawn in February 2008. However, the application has been recently resubmitted following the completion of additional studies to support data for the new indication.
While non-erosive GERD is defined as a set of subjective symptoms such as heartburn caused by the flow of stomach acid and other gastric contents back into the esophagus, it is a disorder in which erosion, ulcers or other mucosal injuries in the esophagus are not observed on endoscopy. As with reflux esophagitis which accompanies mucosal injuries to the esophagus, non-erosive GERD is typified by severe heartburn and a significant decline in quality of life. This means that relieving the stress caused by symptoms by ceasing its subjective symptoms quickly and permanently is extremely important in the treatment of this disorder. Eisai already has approval for this indication in Europe and the United States *, and with this submission it aims to improve the quality of life of non-erosive GERD patients in Japan.
PARIET® has clinically shown a rapid onset of action and a stable inhibitory effect on acid secretion with the approved indications in Japan including stomach ulcers, duodenal ulcers, reflux esophagitis, and as an adjunctive treatment for eradication of Helicobacter pylori bacteria in gastric/duodenal ulcers.
PARIET® was launched first in Japan in 1997. Following that, the product began to be marketed in Europe in 1998 and in the United States in 1999 (the brand name in the U.S.: ACIPHEX®). Currently, the product is approved in 99 countries worldwide.
With this application, Eisai hopes to enhance the clinical value of PARIET® and make further contributions to the treatment of patients with acid related diseases.
* Indication in Europe and the United States is for “Symptomatic GERD.”