Aricept is already approved in the US, Japan and the EU for the treatment of mild to moderate Alzheimer’s disease. Eisai, which markets the drug with its partner Pfizer, has an application pending in the US for the use of Aricept to be expanded to include vascular dementia, the second most common form of dementia after Alzheimer’s disease.
A total of 11 patients from the 648 participants in the arm of the study receiving Aricept (donepezil) have died. There were no reported deaths in the 326 strong placebo group.
Eisai said the deaths had been reported to regulatory authorities and that it would continue to discuss the Aricept VaD program with regulators. However, analysts are wary of the results, saying that even a small increased risk could have significance for the drug. As Aricept’s efficacy in fighting Alzheimer’s is relatively low, its risk profile is particularly important.