|FOR IMMEDIATE RELEASE
December 25, 2007
| For Print (PDF 99KB)
Eisai Introduces New Aricept® Dose Formulations for
Treatment of Severe Alzheimer's Disease in Japan
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) today announced that the company will introduce new dose formulations of Aricept® (donepezil hydrochloride), Aricept® Tablet 10 mg and Aricept® D Tablet 10 mg, for treatment of severe Alzheimer's disease (AD) in Japan on December 26, 2007.
On August 23, 2007, Eisai obtained approval for additional efficacy and dosage for Aricept® for the treatment of severe AD as well as for the marketing authorization for the new 10 mg dose formulations in Japan. The new 10 mg dose formulations were added to the National Health Insurance (NHI) drug price list as of December 21, 2007.
In the treatment of severe AD, dose of Aricept® is increased to 10 mg once daily, after four weeks and later at 5 mg. Currently, Aricept® is marketed in 3 mg tablet or 5 mg tablet formulations. With introduction of 10 mg tablets, one tablet a day administration treatment becomes available for all stages of AD (mild, moderate and severe) which can be beneficial for the patients and their families, as well as their caregivers.
Aricept®, an acetylcholinesterase inhibitor developed by Eisai Co., Ltd., is the only approved prescription medicine for the treatment AD in Japan. It is believed to work by inhibiting the breakdown of acetylcholine, thereby increasing available levels of this chemical in the brain. There is an established association between the loss of acetylcholine, a brain chemical involved in memory and thinking, and AD. In Japan, it has been reported that approximately 1.25 million people have been affected by AD and approximately 300,000 of those are in the severe stage.
Eisai is committed to increase further clinical value of Aricept® in medical practice and to make further contributions to increasing benefits for patients in all stages of AD and their families.
[Please see the following note for information on Aricept®]
Corporate Communications Department
Eisai Co., Ltd.
< Notes to Editor >
- Product Names (new dose formulations are underlined):
“Aricept® Tablet 3 mg”, “Aricept® Tablet 5 mg”, “Aricept® Tablet 10 mg”,
“Aricept® D* Tablet 3 mg”, “Aricept® D Tablet 5 mg”, “Aricept® D Tablet 10 mg” ,
“Aricept® Fine granules 0.5%”.
(*the Aricept® D Tablets are rapid disintegration (RPD) tablet formulations.)
- Indications: inhibition of progress of cognitive disorder in Alzheimer's disease
- Dosage & administration:
The recommended initial dose for adult patients is 3 mg donepezil hydrochloride administered orally once daily. After 1 to 2 weeks, the dose should be increased to 5 mg once daily. For severe Alzheimer's disease patients, administration should be started with 5 mg once daily, and after 4 weeks, the daily dose should be increased to 10 mg. This dose may be decreased when necessary.
- NHI Listed Drug Price
|Product Name||Dose||Price (yen)|
|Aricept® Tablet 3 mg||3mg/tablet||300.40|
|Aricept® D Tablet 3 mg||3mg/tablet||300.40|
|Aricept® Tablet 5 mg||5mg/tablet||452.80|
|Aricept® D Tablet 5 mg||5mg/tablet||454.60|
|Aricept® Fine granules 0.5%||0.5%||423.90(1g)|
|Aricept® Tablet 10 mg||10mg/tablet||792.70|
|Aricept® D Tablet 10 mg||10mg/tablet||792.70|
In the United States., Aricept
® received approval for the treatment of severe Alzheimer's disease in October 2006. Since then, Aricept
® indication for severe AD has been approved in India, Philippines, New Zealand, Canada, Australia and Thailand.