Eisai Co., Ltd. announced that Aricept (donepezil hydrochloride) has been approved for the additional indication of severe Alzheimer's disease in China. Aricept is the first Alzheimer's disease treatment with a broad indication that covers mild to severe Alzheimer's disease in China.

The approval of the additional indication was based on the results of a Phase III clinical study (Study 3391) in China. Study 339 was a multi-center, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of Aricept 10 mg per day in 313 Chinese patients with severe Alzheimer's disease. In this study, Aricept demonstrated a statistically significant improvement in total Severe Impairment Battery scores after 24 weeks compared to placebo, which was the primary endpoint of the study. In the study, the four most commonly observed adverse events in the Aricept arm were bradycardia, anorexia, QT interval prolongation, and dizziness.

In China, it has been estimated that approximately 6 million people suffer from Alzheimer's disease. Furthermore, with the progressive aging of the population, the number of patients with dementia is expected to greatly increase in the future.

With the approval of this indication covering severe Alzheimer's disease, Eisai strives to further contribute to increasing the quality of life of patients with Alzheimer's disease in China, and as the originator of Aricept, continues to make comprehensive contributions in dementia such as improving treatment and care, increasing public awareness of the disease and discovering new treatment methods.