Eisai Alzheimer’s drug to see China review
pharmafile | March 4, 2015 | News story | Sales and Marketing | Alzheimer's, Aricept, China, Eisai, donepezil hydrochloride
Alzheimer’s drug Aricept from Eisai has been accepted for review in China to treat patients with the most severe form of the disease.
Aricept (donepezil hydrochloride) is currently approved to treat mild to moderate Alzheimer’s in China, and in the US the pill is marketed by Pfizer for mild to severe indications.
The review by the Jiangsu Food and Drug Administration in China is based on Phase III study results which demonstrated a significant improvement in total Severe Impairment Battery – assessment of reasoning and awareness – scores after 24 weeks compared to placebo.
The drug reached its primary endpoint of the study and the most commonly observed adverse events were dizziness, diarrhoea and weight loss.
Alzheimer’s is a progressive disease which over time causes damage to parts of the brain triggering symptoms of memory loss and the ability to concentrate. The condition also affects visuospatial skills – problems judging distances.
Alzheimer’s is the most common cause of dementia which can also be triggered by a series of strokes, or in rarer cases by Parkinson’s or Huntington’s diseases.
It is estimated that approximately seven million people in China suffer from dementia – the highest incidence in the world. Furthermore, with the progressive ageing of the population, this figure is expected to greatly increase in the future.
Moreover, the number of patients in England diagnosed with dementia has increased by 62% over the last seven years according to the Health and Social Care Information Centre.
Provisional figures note that more than 344,000 people were diagnosed with dementia in 2013/14, up from 213,000 in 2006/7 when the data were first collected.
A number of pharma firms have been coming together in the last few years in order to develop new medicines for the physical disease that affects the brain. Most recently rivals AstraZeneca and US-based Lilly signed an agreement to develop an experimental pill to treat Alzheimer’s.
The two companies are developing oral beta secretase cleaving enzyme, AZD3298, an inhibitor pill which has shown positive results in Alzheimer’s patients in Phase I studies.
Tom Robinson
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