Eisai Announces Plans to Submit Application for Partial Change to Label for Dosage and Administration of Aricept for Treatment of Dementia with Lewy Bodies Based on Results of Drug Reexamination. announced today that it has received notification that Aricept (donepezil hydrochloride), a treatment for Alzheimer's disease and dementia with Lewy bodies that was discovered and developed in-house, has been granted Category 2* status based on the results of a reexamination of its efficacy, dosage and administration for the treatment of dementia with Lewy bodies (DLB) in Japan. In conjunction with this, Eisai plans to promptly submit an application for a partial change to label regarding dosage and administration. The indication for DLB remains unchanged.
The results of Study 419 did not show a statistically significant difference between the placebo group and the Aricept group in the primary endpoint of global function (CIBIC-plus** comprehensive assessment), but the re-examination based on post-marketing studies, including the results of Study 419, stated that "at present, the evaluation of clinical function in DLB using CIBIC-Plus is not always sufficiently established as an evaluation method, and it is difficult to comprehensively evaluate the efficacy of this drug for DLB, although efficacy was seen in some patients. On the other hand, treatment with this drug showed a trend toward improvement in cognitive function (MMSE***), and this result is consistent with the results of the clinical trial at the time of approval of the drug. Since there are a certain number of patients who can be expected to benefit from the administration of this drug, it was concluded that the efficacy should be evaluated after the start of administration, and administration should only continue if efficacy is confirmed."
Therefore, it was concluded that the approved label (dose and administration) and package insert should be appropriately revised (Category 2).
The condition of the approval was lifted as of the date of receipt of the reexamination results.
Along with this prompt application for a partial change to label regarding dosage and administration for the DLB indication, Eisai will place the highest priority on the provision of proper use and safety information for this drug, and will make continued contributions to address the diversified needs of, and increase the benefits provided to people living with DLB and their families.
For more information, visit www.eisai.com/news/2022/news202274.html.
Public Relations Department,
Eisai Co., Ltd.
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