Eisai Seeks Expanded Indication for Alzheimer's Drug
Posted on: Wednesday, 15 February 2006, 12:00 CST
The FDA has accepted Eisai's supplemental new drug application for Aricept as a treatment for severe Alzheimer's disease.
Aricept, which is co-promoted in the US by Eisai and Pfizer, is currently only approved for treatment of mild to moderate Alzheimer's disease. Eisai Medical Research submitted the revised application on December 16, 2005.
While there is no cure for Alzheimer's disease, medical treatments are available to manage symptoms of the disease. Once-a-day prescription Aricept is indicated for 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.
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.
Source: Datamonitor
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