AsianScientist (Sep. 23, 2014) – Eisai Co. Ltd.’s anti-Alzheimer’s agent Aricept® (donepezil hydrochloride) has received approval for a new indication for dementia with Lewy bodies (DLB) in Japan. This marks the first time a treatment has been approved for DLB anywhere in the world.
DLB was discovered in 1976 by Dr. Kenji Kosaka, Professor Emeritus of Yokohama City University. It is a degenerative form of dementia that is pathologically characterized by decreased neurons in the brain and brainstem and the appearance of vast numbers of inclusions known as Lewy bodies. In neurochemistry, DLB is characterized by a loss of acetylcholine-producing neurons in the brain similar to that seen in patients with Alzheimer’s disease.
DLB is considered to be one of Japan’s three major types of dementia, alongside Alzheimer’s disease and vascular dementia. According to a number of reports, DLB affects between 4.3 percent (based on epidemiology) and 41.4 percent (based on autopsies) of elderly patients with dementia in Japan, with the number of patients increasing due to the aging of the population. DLB is difficult to diagnose because of the overlap in symptoms with other diseases such as Alzheimer’s and Parkinson’s.
The new indication approval was primarily based on a Phase II study and Phase III study conducted by Eisai on patients with DLB in Japan. In accordance with the conditions of approval, Eisai will ensure that an observational study is carried out to gather data on long-term use and an additional clinical trial is performed to confirm efficacy and also promote the appropriate use of Aricept for this additional indication. The registration validity period for Aricept for this indication is four years.
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