FDA accepts Eisai's new application for Aricept for severe Alzheimer's disease

By E. Janene Geiss

Philadelphia, Feb. 14 - Eisai Co., Ltd. and Eisai Inc. said Tuesday that the Food and Drug Administration has accepted a supplemental New Drug Application for Aricept (donepezil Hcl tablets) for treatment of severe Alzheimer's disease.

Eisai Medical Research Inc. submitted the revised application on Dec. 16, according to a company news release.

Aricept, which is co-promoted in the United States by Eisai and Pfizer Inc., is approved for treatment of mild to moderate Alzheimer's disease.

Aricept is an acetylcholinesterase inhibitor and is believed to work by inhibiting the breakdown of acetylcholine, thereby increasing available levels of this chemical in the brain. There is an established association between the loss of acetylcholine, a brain chemical involved in memory and thinking, and Alzheimer's disease, officials said.

In a progressively degenerative disease such as Alzheimer's, improvement, stabilization or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with Aricept in clinical trials for Alzheimer's disease.

Eisai Co., Ltd. is a Tokyo research-based human health care company that discovers, develops and markets products in more than 30 countries. The U.S. pharmaceutical subsidiary is based in Teaneck, N.J.

Pfizer, based in New York City, develops, manufactures and markets leading prescription medicines for humans and animals.

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