Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that its U.K. subsidiary Eisai Ltd. (Headquarters: London, Managing Director: Paul Hooper) filed an application with the MHRA (Medicines and Healthcare Products Regulatory Agency) for a new indication of severe Alzheimer's disease for Aricept
through the Mutual Recognition Procedure in Europe and the 12 Member States involved in the procedure on May 15, 2006 (local time).
The application includes the results of three 6-month placebo-controlled, randomized double-blind studies with severe Alzheimer's disease patients in Sweden, the U.S.1
, and Japan. In these studies, Aricept
was found to be statistically significant on the cognitive function as measured on the SIB2
. In addition, Aricept
showed a statistically significant effect or improvement tendency in ADCS-ADL-severe3
, compared to placebo.
, an acetylcholinesterase inhibitor developed by Eisai Co., Ltd. in Japan, is used in the treatment of mild to moderate Alzheimer's disease and increases the concentration of acetylcholine, a neurotransmitter in the brain. It is estimated that there are about 4.5 million patients with Alzheimer's disease in Europe.
With this application, Eisai is seeking to contribute to a wider population of patients and their caregivers by providing Aricept
as first-line therapy for all patients with Alzheimer's disease including those patients with severe symptoms.
1 The study was conducted worldwide and led by the U.S.
2 SIB: Severe Impairment Battery
3 ADCS-ADL-severe: Modified Alzheimer's Disease Cooperative Study Activities of
Daily Living Inventory
4 CIBIC-plus: Clinician's interview-based impression of change plus caregiver input