Eisai Submits Application to Expand Indication of Anti-Alzheimer's Agent
Aricept(R) as Treatment for Dementia with Lewy Bodies in Japan
Tokyo, Oct 31, 2013 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo,
President & CEO: Haruo Naito), announced today that it has filed an
application for the anti-Alzheimer's agent Aricept(R) (donepezil
hydrochloride, "donepezil") in Japan, requesting a new indication
expansion to use the agent in the treatment of dementia with Lewy bodies
DLB is considered to be one of Japan's three major types of dementia,
alongside Alzheimer's disease and vascular dementia. In addition to
progressive cognitive impairment, the disease presents with features of
parkinsonism as well as visual hallucinations and other characteristic
neuropsychiatric symptoms. No approved treatment for DLB currently exists,
although in Japan the use of acetylcholinesterase inhibitors is recommended in
the treatment of the disease according to major consensus guidelines.
Based on a preceding Phase II study (Study 431) of donepezil in Japanese
patients with DLB, in which donepezil demonstrated significant improvement over
placebo in core efficacy outcome measures such as cognitive function,
behavioral and neuropsychiatric symptoms, and global function, Eisai conducted
a Phase III study (Study 341) to assess the superiority of 12-week donepezil
treatment over placebo in patients with DLB. The co-primary endpoints set for
Study 341 were cognitive function and behavioral and neuropsychiatric symptoms.
In addition, the safety and efficacy of long-term donepezil administration (52
weeks) were also investigated.
The results of Study 341 noted significant improvement in cognitive function
in the donepezil groups compared to the placebo group at the final evaluation
point after 12 weeks of treatment, and cognitive function was also observed to
be maintained at a level higher than at baseline after 52 weeks of treatment.
Improved behavioral and neuropsychiatric symptoms were observed in all
treatment groups, both donepezil and placebo, and suggested no significant
difference among groups at the final evaluation point after 12 weeks of
treatment. Furthermore, adverse events (AEs) in both studies were consistent
with the known safety profile of donepezil and no new or unexpected AEs
With more than 200,000 patients estimated to be living with the disease in
Japan and this number expected to rise due to a rapidly aging population, the
need for new DLB treatments in a clinical setting is increasing. As the
originator of Aricept, Eisai is looking at the realities faced by patients with
dementia in Japan and is working to further contribute to improving their
quality of life (QOL) as well as the QOL of their families and caregivers.
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care
(hhc) company that discovers, develops and markets products throughout the
world. Eisai focuses its efforts in three therapeutic areas: integrative
neuroscience, including neurology and psychiatric medicines; integrative
oncology, which encompasses oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of research
facilities, manufacturing sites and marketing subsidiaries, Eisai actively
participates in all aspects of the worldwide healthcare system. For more
information about Eisai Co., Ltd., please visit www.eisai.com.
Eisai Co., Ltd.
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