EISAI, PFIZER GAIN ADDED INDICATION FOR ALZHEIMER'S DRUG

Eisai and Pfizer announced that the FDA has approved a supplemental new drug application (sNDA) for Aricept (donepezil HCl tablets) for treatment of severe Alzheimer's disease.

With this approval, Aricept becomes the first and only prescription medication to treat the full spectrum of Alzheimer's (mild, moderate and severe). Aricept, which is co-promoted in the United States by Eisai and Pfizer, has been approved in the United States since 1996 for treatment of mild to moderate Alzheimer's.

The new approval was based on results of a six-month, multicenter, randomized, double-blind, placebo-controlled clinical trial involving 248 Swedish nursing home patients with severe Alzheimer's (Mini Mental State Exam scores of one to 10). The study, the first to evaluate Aricept 10 mg once daily exclusively in patients with severe Alzheimer's, was published in the March issue of Lancet. Patients treated with Aricept had statistically significant benefit compared with 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.

Aricept is the No. 1 prescribed Alzheimer's disease therapy worldwide, with more than 3 billion patient days of Aricept therapy, according to the companies. Nearly 2.3 million people in the United States alone have taken the drug.