Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that its application for a partial change to label for Aricept® (donepezil hydrochloride), a treatment for Alzheimer’s disease and dementia with Lewy bodies (DLB) that was discovered and developed in-house, regarding dosage and administration for the treatment of DLB in Japan, has been approved today. (Please refer to “Notes to Editors” for details of the changes)
This partial change to label is based on the results of a reexamination for the indication of “suppression of progression of dementia symptoms in dementia with Lewy bodies” of this drug, which was categorized as Category 2*.
After receiving approval for the partial change in dosage and administration for DLB, Eisai will continue to 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
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[Notes to Editors]
１． Changes to the Aricept (donepezil hydrochloride) label for dementia with Lewy bodies (changes are underlined)
Dosage and Administration
| Label Prior to Revision | Revised Label |
| Suppression of progression of dementia symptoms in dementia with Lewy bodies
The usual initial adult dose for oral use is 3 mg of donepezil hydrochloride once daily. After 1 to 2 weeks the dose is increased to 5 mg. The dose is increased to 10 mg after dosing at 5 mg for 4 or more weeks. The dose can be reduced to 5 mg according to patients’ symptoms.
|
Suppression of progression of dementia symptoms in dementia with Lewy bodies
The usual initial adult dose for oral use is 3 mg of donepezil hydrochloride once daily. After 1 to 2 weeks the dose is increased to 5 mg. The dose is increased to 10 mg after dosing at 5 mg for 4 or more weeks. The dose can be reduced to 5 mg according to patients’ symptoms. Efficacy should be evaluated by cognitive function tests and interviews with patients and their family members/caregivers about subjective and objective symptoms up to 12 weeks after the start of treatment. If the benefits cannot be judged to outweigh the risks based on a comprehensive evaluation of cognitive function, behavioral and neuropsychiatric symptoms, and activities of daily living, the drug should be discontinued. In the event that, based on the results of efficacy evaluation up to 12 weeks after the start of dosing, the decision is made to continue dosing, periodic efficacy evaluations should be conducted to determine whether dosing should be continued. |
２． About Post-Marketing Clinical Study 419
Study 419 is a post-marketing clinical trial conducted in accordance with the condition of approval established at the time of the September 2014 approval of the indication for the suppression of progression of dementia symptoms in dementia with Lewy bodies (DLB). The study was conducted as a placebo-controlled, double-blind, parallel-group, randomized, study to evaluate the efficacy of 12 weeks of treatment with Aricept in 140 people living with DLB, with global function (CIBIC-plus comprehensive assessment) as the primary endpoint. In the Aricept group, 3 mg was administered once daily during weeks 1-2, 5 mg during weeks 3-6, and 10 mg during weeks 7-12. The results of the Study 419 did not show a statistically significant difference in efficacy between the placebo and Aricept groups at the time of the final analysis in the primary endpoint, the CIBIC-plus comprehensive assessment. Regarding safety, no new issues were observed in the frequency or severity of adverse events compared to those observed in previous clinical studies. In the reexamination, it was determined that the products efficacy for dementia symptoms in DLB is not completely negated by Study 419, and that some patients could be expected to benefit, considering the results on cognitive function (MMSE) in Phase II study (Study 431) and Phase III study (Study 341) at the time of approval. The results of this study will be published in a future paper, etc.
* Category 2: Partial changes in approval (modifications in approved items as directed)
** CIBIC-plus (the Clinician’s Interview-Based Impression of Change plus caregiver input): a validated clinical instrument used to measure change in global function through an interview with patients and their caregivers. Patients are evaluated by an assessor who is independent from the attending physician on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse) in four major categories: General, Mental/Cognitive State, Behavior, and Activities of Daily Living.
*** MMSE (Mini-Mental State Examination): A method for assessing cognitive function. Comprised of the categories orientation, memorization, attention, calculation, recent and distant memory, comprehension, reading and writing, as well as design. Test scores range from 30 (normal) to 0 (severely impaired).
