U.S. FDA Approves Aricept For Treatment of Severe Alzheimer's Disease
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) today announced that the company's U.S. research subsidiary, Eisai Medical Research Inc. (Headquarters: New Jersey, President: Mindell Seidlin), received approval on October 13 (EST) from the U.S. Food and Drug Administration (FDA) for a supplemental New Drug Application for Aricept in the treatment of severe Alzheimer's disease (AD). With this approval, Aricept becomes the first and only prescription medication to treat the full spectrum of AD (mild, moderate and severe). An application for the indication of severe AD has also been submitted in Japan and in Europe.
The approval was based on the results of a pivotal six-month, multi-center, randomized, double-blind, placebo-controlled clinical trial involving 248 patients with severe AD. Results of the study showed that patients treated with Aricept had statistically significant benefit compared to those taking placebo in cognition and function/activities of daily living, which were the primary efficacy measures in the trial. The notable adverse events in Aricept-treated patients in this clinical trial were diarrhea, anorexia, vomiting, nausea and bruising.
In the United States, AD affects approximately 4.5 million people and about 20 percent of people with AD are in the severe stage.
Eisai believes that FDA's approval of Aricept for severe AD, making it the only therapy in the United States for all stages of AD, will help increase benefits to patients and their families/caregivers.
Corporate Communications Department
Eisai Co., Ltd.
[Please see the attached for the information about the clinical trial]
< About the Clinical Trial >
The approval was supported by 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).
In the trial, patients treated with Aricept had statistically significant benefit compared to those taking placebo in both primary efficacy measures: the Severe Impairment Battery for cognition and the Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease for function/activities of daily living.
Treatment with Aricept was generally well tolerated. The notable adverse events in Aricept-treated patients in this trial were diarrhea, anorexia, vomiting, nausea and bruising. The rate of discontinuation due to an adverse event was 15.6 percent in the Aricept-treated patients and 6.7 percent in placebo-treated patients.
The study, the first to evaluate Aricept exclusively in patients with severe AD, was published March 23, 2006 in The Lancet.