Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO Haruo Naito) announced today that on August 31, its U.S. subsidiary, Eisai Medical Research Inc. (Headquarters: New Jersey, President Mindell Seidlin, MD), submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for ARICEPT
(donepezil HCl tablet) for treatment of severe Alzheimer's disease (AD).
The submission is based on data from a six-month, multi-center, randomized, double-blind, placebo-controlled clinical trial conducted in approximately 250 nursing home patients with severe AD. In the pivotal study, patients with severe AD (Mini Mental State Examination scores 1-10) treated with ARICEPT
had a statistically significant improvement compared to those taking placebo on both primary measures of efficacy: the Severe Impairment Battery (SIB scale) and the Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS ADL severe scale). The SIB measures cognition in a more severe population. The ADCS ADL measures patient function and ability to conduct activities of daily living.
, 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.
In the U.S., the numbers of AD patients are estimated at 4.5 million. One out of 10 people over 65 years old , and about one half of people over 85 years old respectively, have Alzheimer's disease. Eisai seeks that ARICEPT
would be the first Alzheimer's medication to treat all stages of the disease.
is currently marketed in 76 countries worldwide and sales forecast for this fiscal year is approximately
Corporate Communications Department
Eisai Co., Ltd.