ROCKVILLE, Md. -- Aricept (donepezil), a cholinesterase inhibitor on the market for mild to moderate Alzheimer's disease, today became the first of its class to win FDA approval for severe disease.
ROCKVILLE, Md., Oct. 13 -- Aricept (donepezil), a cholinesterase inhibitor on the market for mild to moderate Alzheimer's disease, today became the first of its class to win FDA approval for severe disease.
The FDA action made Aricept the only drug approved to treat all stages of Alzheimer's.
The FDA decision was based on efficacy demonstrated in two randomized, placebo-controlled 24-week trials in Sweden and Japan. The trials enrolled more than 500 patients with severe Alzheimer's dementia.
Both trials evaluated Aricept's efficacy with standard measures that assessed cognitive function including memory, language, orientations, and attention as well as overall functioning. The patients randomized to Aricept had better scores than patients in the placebo arms of both studies.
Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, said 4.5 million Americans are affected by Alzheimer's disease and the action by the FDA "makes available another treatment those with severe dementia."
The FDA has approved five drugs for treatment of Alzheimer's symptoms. In addition to Aricept, three others are cholinesterase inhibitors. They are Exelon (rivastigmine), Razadyne (galantamine) and Cognex (tacrine), all approved for mild to moderate disease.
The fifth drug, Nameda (memantine), is a N-methylD-aspartate (MNDA) antagonist, which was approved by the FDA three years ago for treatment of moderate to severe Alzheimer's.
Aricept is manufactured by Eisai Inc., Teaneck, N.J.