Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) announced that on December 11, its UK subsidiary, Eisai Ltd. (Headquarters: London, President: Paul Hooper) submitted a type II variation for PARIET (rabeprazole sodium), a proton pump inhibitor, for the treatment of Zollinger-Ellison syndrome (ZES) and other pathological hypersecretory conditions to the Medicines and Healthcare products Regulatory Agency (MHRA) which will act as the Reference Member State for the European Union's (EU) Mutual Recognition procedure.
In pathological hypersecretory conditions, acid secretion is excessive in stomach. Patients in such conditions often experience symptoms such as upper abdominal pain or diarrhea. Pathological hypersecretory conditions are typically represented by ZES, where high levels of gastrin secretion from tumors in the pancreas or the small intestine leads to the increased gastric acid level.
The product has already been approved for the treatment of ZES in Japan, and for the pathological hypersecretory conditions including ZES in the United States under the brand name ACIPHEX .
PARIET was launched in the EU in 1998. Eisai's marketing subsidiaries market PARIET in the United Kingdom and Germany. Janssen-Cilag markets the product in the other European countries. PARIET was first launched in 1997 in Japan, and it was launched as ACIPHEX in 1999 in the United States. Currently, the product has been launched in 70 countries worldwide.
Since its establishment, Eisai has been committed to developing drugs for the treatment of gastrointestinal diseases. The company hopes to contribute further to the treatment of acid-related diseases.
Eisai Co., Ltd.
Public Relations Department