MONDAY, Oct. 16 (HealthDay News) -- The U.S. Food and Drug Administration has granted Aricept (donepezil hydrochloride) approval for use in Alzheimer disease patients with severe dementia. The drug, made by Eisai Inc., of Teaneck, N.J., is already approved for Alzheimer disease patients with mild to moderate dementia.
The FDA approval came after two studies involving more than 500 patients with severe Alzheimer disease in Sweden and Japan found that those taking Aricept exhibited better memory, attention, orientation, language and general cognitive functions than those taking placebo.
Ten years ago, Aricept won FDA approval after two studies showed that Alzheimer disease patients treated with the drug did better than those on placebo.
"Alzheimer 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," Steven Galson, M.D., director of the FDA Center for Drug Evaluation and Research, said in a statement. "Today's approval makes available another treatment for those with severe dementia."
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