Non-Approvable Letter Received from FDA for ARICEPT for VaD Treatment Indication
Eisai Medical Research Inc. (Headquarters: New Jersey, President: Mindell Seidlin, M.D.), and Eisai Inc. (Headquarters: New Jersey, Chairman: Soichi Matsuno) announced that they received July 3 (U.S. EDT) a non-approvable letter from the U.S. Food and Drug Administration (FDA) for ARICEPT for the treatment of vascular dementia (VaD). Eisai will continue to work with the FDA toward our goal of bringing ARICEPT to patients with VaD.
ARICEPT , an acetylcholinesterase inhibitor synthesized by Eisai Co., Ltd. in Japan, increases the concentration of acetylcholine, a neurotransmitter in the brain. ARICEPT currently is indicated for the treatment of mild to moderate Alzheimer's disease and is marketed in more than 60 countries worldwide, including Japan, the United States, the United Kingdom, Germany and France. With a strong franchise in neurology, Eisai is devoted to the research and development of new treatments to meet unmet medical needs in therapeutic areas such as Alzheimer's disease, Parkinson's disease, epilepsy, and multiple sclerosis.