Top Page | English | 简体中文 | 繁體中文 | 한국어 | 日本語
Wednesday, 13 December 2017, 15:59 HKT/SGT
Share:
    

Source: Eisai
Eisai's Aricept Approved for Additional Indication of Severe Alzheimer's Disease in China

TOKYO, Dec 13, 2017 - (JCN Newswire) - Eisai Co., Ltd. announced today that Aricept (donepezil hydrochloride) has been approved for the additional indication of severe Alzheimer's disease in China. Aricept is the first Alzheimer's disease treatment with a broad indication that covers mild to severe Alzheimer's disease in China.

The approval of the additional indication was based on the results of a Phase III clinical study (Study 3391) in China. Study 339 was a multi-center, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of Aricept 10 mg per day in 313 Chinese patients with severe Alzheimer's disease. In this study, Aricept demonstrated a statistically significant improvement in total Severe Impairment Battery scores after 24 weeks compared to placebo, which was the primary endpoint of the study. In the study, the four most commonly observed adverse events in the Aricept arm were bradycardia, anorexia, QT interval prolongation, and dizziness.

In China, it has been estimated that approximately 6 million people suffer from Alzheimer's disease.1 Furthermore, with the progressive aging of the population, the number of patients with dementia is expected to greatly increase in the future. Eisai launched Aricept in China in September 1999, and in collaboration with various stakeholders including government, hospitals and non-government organizations, is actively promoting dementia disease awareness initiatives for civilians as well as support for establishing memory clinics and other initiatives.

With the approval of this indication covering severe Alzheimer's disease, Eisai strives to further contribute to increasing the quality of life of patients with Alzheimer's disease in China, and as the originator of Aricept, continues to make comprehensive contributions in dementia such as improving treatment and care, increasing public awareness of the disease and discovering new treatment methods.

About Aricept in China

Eisai launched Aricept in China in September 1999. The indication for Aricept in China covers mild to moderate Alzheimer's disease, and can be used in either 5 mg or 10 mg dosages. By obtaining approval for severe Alzheimer's disease, Aricept is the first Alzheimer's disease treatment with a broad indication that covers mild to severe Alzheimer's disease in China.

About the Phase III Clinical Study Conducted in China (Study 339)(1)

Study 339 was a multi-center, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of Aricept 10 mg per day in 313 Chinese patients with severe Alzheimer's disease. Patients were in the Aricept arm received 5 mg for 6 weeks and 10 mg for the remaining 18 weeks (24 weeks in total). From the results of this study, the change in Severe Impairment Battery scores(2) from baseline at week 24, the study's primary endpoint, was 2.9 for Aricept compared to -2.0 for placebo, suggesting a statistically significant improvement for Aricept (difference: 4.8, 95% confidence interval [CI] 1.56 to 8.08, p=0.004). In the study's secondary endpoint of change in CIBIC-plus scores(3), Aricept demonstrated a statistically significant difference compared to placebo (difference: -0.4, 95%CI -0.66 to 0.03, p=0.04), suggesting that treatment with Aricept is clinically meaningful compared to placebo. However, in change in MMSE scores(4) from baseline, another secondary endpoint of the study, a statistically significant difference was not observed between the Aricept and placebo arms. In the study, adverse events were observed in 26.7% of patients in the Aricept arm, and the four most commonly observed adverse events in the Aricept arm were bradycardia (5.7%), anorexia (4.5%), QT interval prolongation (3.8%), and dizziness (3.2%).

(1) Jia J, Wei C, Jia L, et al. Efficacy and safety of donepezil in Chinese patients with severe Alzheimer's disease: A randomized controlled trial. J. Alzheimers Dis 2017; 56: 1495-1504.
(2) Severe Impairment Battery: A validated clinical instrument used to measure severely impaired cognitive function. Patients are evaluated in an interview that assesses cognitive function in nine domains: Social Interaction, Memory, Orientation, Attention, Praxis, Visuospatial, Language, Construction, and Name Orientation. Test scores range from 100 (normal) to 0 (severely impaired).
(3) 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.
(4) 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).


About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our human health care philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com.

Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120


Dec 13, 2017 15:59 HKT/SGT
Source: Eisai

Eisai (TSE: 4523)

Topic: Press release summary
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2018 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.



Eisai
Sept 5, 2018 14:28 HKT/SGT
Eisai And Merck & Co. Announce China NMPA Approval of First Approval for LENVIMA (Lenvatinib) for Treatment of Unresectable HCC
Sept 3, 2018 14:50 HKT/SGT
Eisai Receives Approval for Partial Label Change for Vascular Embolization Device DC Bead
Aug 30, 2018 09:36 HKT/SGT
Eisai's LENVIMA (LENVATINIB) Capsules Approved for First-Line Treatment of Unresectable Hepatocellular Carcinoma (HCC) in South Korea
Aug 29, 2018 10:25 HKT/SGT
Biogen and Eisai Report Data from Long-Term Extension Phase 1b Study of Investigational Alzheimer's Disease Treatment Aducanumab
Aug 28, 2018 09:11 HKT/SGT
Eisai: Long-Term Cardiovascular Outcomes Data for Anti-Obesity Agent BELVIQ
Aug 23, 2018 08:00 HKT/SGT
Eisai: European Commission Grants Marketing Authorization for LENVIMA (Lenvatinib)
July 31, 2018 14:13 HKT/SGT
Eisai Signs Collaboration Agreement for Anti-Obesity Agent Lorcaserin in China to CY Biotech
July 31, 2018 10:27 HKT/SGT
Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Announce U.S. FDA Grants Breakthrough Therapy Designation for LENVIMA
July 26, 2018 10:34 HKT/SGT
Eisai and Biogen Announce Detailed Results of Phase II Clinical Study of BAN2401 in Early Alzheimer's Disease at AAIC 2018
July 26, 2018 08:01 HKT/SGT
Eisai and Biogen Present Detailed Results from Phase II Clinical Study of Elenbecestat in MCI and Mild to Moderate Alzheimer's Disease at AAIC 2018
More news >>
 News Alerts
Copyright © 2018 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Privacy Policy | Terms of Use | RSS
US: +1 800 291 0906 | Beijing: +86 10 8405 3688 | Hong Kong: +852 2217 2912 | Singapore: +65 6304 8926 | Tokyo: +81 3 6721 7212

Connect With us: