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Press ReleasesFor Immediate Release: 10/16/2006 U.S. Food and Drug Administration Approves ARICEPT® for Treatment of Severe Alzheimer's DiseaseFirst and Only Treatment Approved for the Full Spectrum of Alzheimer's Disease - Mild, Moderate and SevereTeaneck, NJ and New York, October 13, 2006 ― Eisai and Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for ARICEPT® (donepezil HCl tablets) for treatment of severe Alzheimer's disease (AD). The application was submitted by Eisai Medical Research Inc. (Headquarters: Ridgefield Park, President Mindell Seidlin, MD) on behalf of Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO Haruo Naito) and Eisai Inc. (Headquarters: Teaneck, NJ, Chairman and CEO Hajime Shimizu). With this approval, ARICEPT becomes the first and only prescription medication to treat the full spectrum of AD (mild, moderate and severe). ARICEPT, which is co-promoted in the United States by Eisai Inc. and Pfizer Inc, has been approved in the United States since 1996 for treatment of mild to moderate AD. "For the first time ever, the millions of people affected by Alzheimer's disease and the families, caregivers and healthcare professionals who care for them now have a once-daily therapy, Aricept, to treat the symptoms of every stage of this disease,” said Sharon Richardson, Ph.D., senior director, Medical Affairs, Eisai Inc. “This milestone exemplifies Eisai's and Pfizer's commitment to improving the lives of families living with Alzheimer's disease and advancing the scientific understanding of this devastating form of dementia.” The approval was based on results of a pivotal six-month, multi-center, randomized, double-blind, placebo-controlled clinical trial involving 248 Swedish nursing home patients with severe AD (Mini Mental State Exam scores 1-10). The study, the first to evaluate ARICEPT® (donepezil HCl tablets) 10 mg once-daily exclusively in patients with severe AD, was published March 2006 in The Lancet. Patients treated with ARICEPT had statistically significant benefit compared to those taking placebo in both primary efficacy measures: the Severe Impairment Batt |
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