First Approval Of Eisai's Aricept For Alzheimer's

Eisai America has received approval from the US Food and Drug Administration for Aricept (donepezil hydrochloride), previously code-named E2020, for the symptomatic treatment of mild-to-moderate Alzheimer's disease. This is the first approval for the reversible acetylcholinesterase inhibitor worldwide.

Eisai America, the alliance between US company Pfizer and Eisai of Japan, said that the product will be marketed shortly after the New Year in 5mg and 10mg tablets for once-daily dose administration. Pfizer has copromotion rights in the USA and also in certain European markets. As part of the promotion, Pfizer will offer diagnostic tools for physicians and caregivers to monitor the progression of the disease, according to Pat Kelly, Pfizer's vice president of disease management.

The initial recommended dose is 5mg/day, but data from clinical trials has suggested that some patients may receive further benefit by raising the dose to 10mg/day after four to six weeks on the lower dose.