Eisai Receives confirmation that Aricept (donepezil hydrochloride), Orodispersible Tablet has successfully completed the Mutual Recognition Procedure in the 12 EU countries
Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) announced that its U.K. subsidiary, Eisai Ltd. (Headquarters: London, Managing Director: Paul Hooper), has received notification of the completion of the Mutual Recognition Procedure (MRP) from the Medicines and Healthcare products Regulatory Agency (MHRA) on December 22 (London time) for Aricept orodispersible tablet. The MHRA confirmed that all 12 Member States involved in the procedure have mutually recognised the UK national licence approved by the MHRA earlier this year. The 12 Member States are Germany, France, Italy, Austria, Belgium, Denmark, Luxembourg, Finland, Greece, Ireland, Portuagal, and Sweden. All 12 Member States will now issue their own national licences in due course.
Aricept orodispersible tablet is designed to make administration easier for Alzheimer's disease patients who have difficulty swallowing tablets, in order to contribute to many patients by this new formualtion. The company has already started marketing an orodispersible tablet of Aricept in Japan since July 2004. In the U.S., Eisai started marketing orodispersible tablets from June 2005, and received approval in May 2005 in the UK.
Aricept, an acetylcholinesterase inhibitor developed by Eisai Co., Ltd. in Japan, increases the concentration of acetylcholine, a neurotransmitter in the brain. Aricept is currently indicated for the treatment of mild to moderate Alzheimer's disease.
Eisai covers the major regions in Europe, and is making efforts to enhance its pharmaceutical sales structure in Europe. Through the new formulation approval of Aricept orodispersible tablet, Eisai will contribute to the medical benefits of patients in the EU through the enhancement of easier administration for Alzheimer's disease patients.
Corporate Communications Department
Eisai Co., Ltd.