FDA Approves Larger Dose Of Pfizer's Aricept
From Associated Press (July 25, 2010)
NEW YORK -- Drug makers 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.
Posted: July 2010