Pfizer and Eisai say FDA approves bigger dose of Aricept drug for Alzheimer’s disease

FDA approves larger dose of Pfizer’s Aricept

NEW YORK — Drugmakers Eisai Inc. and Pfizer Inc. said on Saturday that government regulators have given them permission to make a larger dose of its Alzheimer’s disease drug Aricept for patients who have already been taking the smaller dose.

Aricept is the version of the drug donepezil, and is co-marketed by Eisai, of Japan, and Pfizer. Its 2009 revenue for Pfizer was $432 million, with another $3.3 billion for Eisai, making it the largest seller out of four drugs that can temporarily reduce Alzheimer’s symptoms.

The companies said the higher dose improved scores on a patient test that measures cognition. There was no difference on a different test that measures global function.

Approval by the Food and Drug Administration followed a study of 1,467 patients with moderate to severe Alzheimer’s. It said the larger dose is recommended for patients who are already taking smaller doses daily for at least three months.