Eisai Medical Research Inc. has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for Aricept (donepezil HCl tablets) for treatment of severe Alzheimer's disease (AD). Aricept, which is co-promoted in the United States by Eisai Inc. and Pfizer Inc, is currently approved for treatment of mild to moderate AD.
"Our goal to provide Aricept to people with severe Alzheimer's disease is consistent with Eisai's human health care mission to improve the lives of patients and their families," said Lonnel Coats, president and COO, Eisai Inc.
The August 31 submission is based on data from a six-month, multi-centre, 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.