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FDA Approves Expanded Use of Treatment for Patients With Severe Alzheimer's Disease

BETHESDA, MD -- October 13, 2006 -- The Food and Drug Administration (FDA) today approved Aricept (donepezil hydrochloride) for the treatment of severe dementia in patients with Alzheimer's Disease.

Aricept was previously approved for the treatment of mild to moderate dementia of the Alzheimer's type. It now becomes the first product approved for the treatment of all degrees of severity of the disease.

"Alzheimer's Disease is a devastating, age-associated brain disorder that affects an estimated 4.5 million Americans -- and, as our population grows older, this number is expected to multiply," said Dr. Steven Galson, director of the Center for Drug Evaluation and Research. "Today's approval makes available another treatment for those with severe dementia."

FDA approved Aricept to treat patients with mild to moderate Alzheimer's Disease ten years ago after two clinical trials demonstrated that patients receiving the drug performed better than patients who received placebo. Today's approval is based on two additional randomized, placebo-controlled, 24-week clinical studies conducted in Sweden and Japan in more than 500 patients with severe Alzheimer's Disease.

In these studies, the effectiveness of treatment with Aricept was determined by evaluating the patients' cognitive functions such as memory, language, orientation and attention, as well as their overall functioning. The results showed that patients on Aricept performed better on both measures compared to placebo.

Aricept is manufactured by Eisai Inc., Teaneck, New Jersey.


SOURCE: Food and Drug Administration

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