Eisai Medical Research submitted the revised application after the FDA rejected the original filing, submitted in August 2005, due to deficiencies in its format. Aricept, which is co-promoted in the US by Eisai and Pfizer, is currently approved for treatment of mild to moderate Alzheimer’s disease.
In the FDA’s usual procedure, an acceptance decision regarding the sNDA resubmission will be made within 60 days after receipt and review of its contents.
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.