Eisai Co., Ltd. today announced that the company's U.S. research subsidiary, Eisai Medical Research Inc., 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.