Eisai Limited (Headquarters: London, Managing Director: Paul Hooper), a U.K. subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) announced today that it has withdrawn its application for a vascular dementia indication for Aricept(donepezil hydrochloride). The application had been submitted through the mutual recognition procedure in the European Union (EU).
Eisai will expedite the ongoing clinical studies to evaluate the use of Aricept for the treatment of vascular dementia. Once additional supportive data have been obtained, Eisai will submit the additional data to the U.S. Food and Drug Administration (FDA) and resubmit in the EU.
Corporate Communications Department
Eisai Co., Ltd.