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US FDA rejects Eisai's Aricept due to formatting defeciencies

Tokyo, JapanThursday, November 3, 2005, 08:00 Hrs  [IST]

The US Food and Drug Administration did not accept Eisai Co. Ltd. and Eisai Incs' supplemental new drug application (sNDA) for Aricept (donepezil HCl tablets) for treatment of severe Alzheimer's disease (AD) because of deficiencies in the format of the application. Aricept, which is co-promoted in the United States by Eisai Inc. and Pfizer Inc, is currently approved for treatment of mild to moderate AD. Eisai Medical Research Inc., which submitted the sNDA on behalf of Eisai Co. Ltd. and Eisai Inc. on August 31, 2005, plans to resolve these issues and resubmit the sNDA in mid-December 2005. The submission was based on results of a pivotal six-month, multi-center, randomized, double-blind, placebo-controlled clinical trial involving 248 nursing home patients with severe AD, states a company release. AD is a progressive brain disease that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. AD affects 4.5 million Americans. One in 10 persons over age 65 have AD, and nearly half of those over 85 have it. 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. Individual responses to treatment vary, and some patients may not respond. The release further informs that Aricept is the number one prescribed Alzheimer's disease therapy worldwide, with more than 2.5 billion patient days of Aricept therapy. Nearly 2.3 million people in the United States alone have taken Aricept. Aricept is co-promoted in the United States by Eisai Inc. and Pfizer Inc, which are dedicated to advances in Alzheimer's therapy.

 
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