TOKYO and TEANECK, N.J., Dec. 19 /PRNewswire/ -- Eisai Co., Ltd. and Eisai Inc. (Headquarters: Teaneck, NJ, Chairman and CEO Hajime Shimizu) announced today that a reformatted version of the supplemental New Drug Application (sNDA) for ARICEPT(R) (donepezil HCl tablets) for treatment of severe Alzheimer’s Disease has been resubmitted to the U.S. Food and Drug Administration (FDA). Eisai Medical Research Inc. (Headquarters: Ridgefield Park, President Mindell Seidlin, MD) submitted the revised application on December 16, 2005. The sNDA was originally submitted on August 31, 2005, but the FDA did not accept the application for filing due to deficiencies in its format.
An acceptance decision regarding the sNDA resubmission will be made by FDA within 60 days after receipt and review of its contents, according to FDA’s usual procedure. Eisai will issue a press release to announce the status.
ARICEPT, which is co-promoted in the United States by Eisai Inc. and Pfizer Inc, is currently approved for treatment of mild to moderate Alzheimer’s disease.
Information About ARICEPT Treatment in Alzheimer’s disease
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.
ARICEPT is well tolerated but may not be for everyone. Some people may have nausea, diarrhea, not sleep well or vomit. Some people may have muscle cramps, feel very tired, or may not want to eat. In studies, these side effects were usually mild and went away over time. People at risk for stomach ulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse. Some people who take ARICEPT may experience fainting.
For more information about managing Alzheimer’s disease and about ARICEPT, and for prescribing information on ARICEPT, please see accompanying full prescribing information or visit http://www.aricept.com.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care company that discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs more than 8,000 people worldwide.
About Eisai Medical Research Inc.
Eisai Medical Research Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd. Eisai Medical Research Inc. was established to focus on clinical research and to expedite clinical drug development of new chemical entities and of new indications for marketed products.
About Eisai Inc.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of approximately $2 billion in fiscal year 2004 (year ended March 31, 2005).
Eisai Inc.
CONTACT: Judee Shuler of Eisai Inc., +1-201-287-2241
