FDA Approves Aricept for Severe AD

Eisai and Pfizer received FDA approval for an sNDA for Aricept for the treatment of severe Alzheimer’s disease (AD). With this approval, Aricept becomes the only prescription medication to treat mild, moderate and severe AD. Aricept, which is co-promoted in the U.S. by Eisai and Pfizer, has been approved in the U.S. since 1996 for treatment of mild to moderate AD.

The approval was based on results from a multi-center, randomized, double-blind, placebo-controlled trial involving 248 patients with severe AD. Patients treated with Aricept had statistically significant benefit compared to those taking placebo in both primary efficacy measures: the Severe Impairment Battery for cognition and the Modified Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer’s Disease for function/activities of daily living.