FDA approves Aricept for severe Alzheimer’s disease

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

The approval was based on results of a pivotal six-month clinical trial the first to evaluate Aricept once-daily exclusively in patients with severe Alzheimer’s. Patients treated with Aricept had statistically significant benefit compared to those taking placebo.

“Aricept has been proven effective and well tolerated to help treat the symptoms of mild to moderate Alzheimer’s disease,” said Rachelle Doody, professor of Neurology, Baylor College of Medicine. “With this approval, we now know that Aricept can provide benefit in memory, thinking and activities of daily living in people with severe Alzheimer’s disease.”

Alzheimer’s affects about 4.5 million Americans.