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EISAI RECEIVES APPROVAL FOR ADDITIONAL INDICATION OF PROTON PUMP INHIBITOR PARIET® FOR NON-EROSIVE GERD IN JAPAN

°®¶¹´«Ã½. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced today that the Company has received approval for an additional indication of its proton pump inhibitor Pariet® (generic name: rabeprazole sodium) for non-erosive gastroesophageal reflux disease (GERD) in Japan.

While non-erosive GERD is defined by the presence of subjective symptoms, most notably heartburn, caused by stomach acid and other gastric contents flowing back into the esophagus, it is a disorder in which there is an absence of endoscopically-visible esophageal mucosal injury such as erosion or ulceration. As with reflux esophagitis, in which mucosal injury in the esophagus is in fact present, non-erosive GERD is characterized by severe heartburn and a significant decline in quality of life. This means that resolving subjective symptoms quickly and permanently and thus relieving the stress they cause is extremely important in the treatment of this disorder.

Pariet® inhibits proton pumps during the last phase of stomach acid secretion and has been clinically shown to have a rapid onset of action and a powerful inhibitory effect on acid secretion. In Japan, the drug is indicated for the treatment of gastric ulcers, duodenal ulcers, reflux esophagitis, and as an adjunctive treatment in the eradication of Helicobacter pylori bacteria in gastric and duodenal ulcers. The clinical value of Pariet® in treating patients with acid related diseases has been further enhanced with the approval of non-erosive GERD as an additional indication.

Pariet® was launched first in Japan in 1997, and subsequently made available in Europe in 1998, and the United States in 1999, where it is marketed under the brand name AcipHex®. Currently approved in more than 90 countries worldwide, Pariet® has already been approved for the treatment of non-erosive-GERD in Europe and the United States*.

By providing Pariet® as a new treatment option for non-erosive GERD in Japan, Eisai seeks to make further contributions to the treatment of patients with acid-related diseases in hope of improving their quality of life.

  • *
    Indication in Europe and the United States is for “Symptomatic GERD.”

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