Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) announced that its U.K. marketing subsidiary, Eisai Limited. (Headquarters: London, Managing Director: Paul Hooper), has submitted an application for a modification to the Posology and Method of Administration section of the PARIET SmPC on September 11, 2003. The application is for on-demand therapy of moderate to very severe symptomatic gastro-oesophageal reflux disease (symptomatic GORD). It was submitted 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.
PARIET is currently approved for symptomatic GORD treatment in the E.U. With 'on-demand' therapy in the E.U., patients would take PARIET 10 mg once daily, whenever a heartburn episode recurs, until the symptoms are relieved.
PARIET was launched in the E.U. 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.