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www.fdanews.com/articles/63461-aricept-approved-to-treat-all-forms-of-alzheimer-s-dementia

ARICEPT APPROVED TO TREAT ALL FORMS OF ALZHEIMER'S DEMENTIA

October 23, 2006

Aricept has become the first drug approved to treat mild, moderate and severe forms of dementia from Alzheimer's disease.

The FDA approved the expanded indication for Aricept (donepezil HCl) on Oct. 13. The drug had previously been approved to treat mild to moderate forms of the disease.

The approval came after two studies conducted in Sweden and Japan showed that patients on Aricept had better cognitive and overall functioning than patients on a placebo. The tested cognitive functions included memory, language, orientation and attention. More than 500 patients with severe Alzheimer's disease were part of the study.

Ten years ago, the FDA approved Aricept to treat the mild to moderate forms of Alzheimer's after two clinical trials. Patients in those studies taking Aricept also performed better in cognitive and overall functioning than those taking a placebo.

Approximately 4.5 million Americans have Alzheimer's disease, according to the National Institute on Aging, and that number is expected to grow as the population ages.