Japanese Regulators Approve Aricept for Additional Efficacy and Dosage

Japanese drugmaker Eisai reported that it has received approval for additional efficacy and dosage of Aricept for the treatment of severe Alzheimer’s disease in Japan.

With this approval, Aricept (donepezil hydrochloride) is now approved to treat mild, moderate and severe Alzheimer’s.

According to Eisai, the approval was based on the results of clinical trials conducted in Japan and abroad. The six-month, multicenter, randomized, double-blind, placebo-controlled Japanese trial, which involved approximately 300 patients with severe Alzheimer’s, compared the efficacy of 5- and 10-mg/day doses versus placebo.

In the study, the patients treated with both doses of Aricept showed a statistically significant improvement in cognitive function compared with those taking placebo, the company said.

Aricept is the only approved prescription medicine for the treatment of Alzheimer’s in Japan.