Eisai has stongly denied claims that its withdrawal of a supplemental European application for the use of Aricept in the treatment of severe Alzheimer’s disease is linked to the decision by the National Institute for Health and Clinical Excellence to limit the use of AChE inhibitors in the treatment of the disease.
The Tokyo-based company was asked by the European Medicines Agency to provide additional data showing that Aricept (donepezil) led to improvements in daily living activities in patients with severe Alzheimer’s. The agency had already accepted that the treatment improves cognition.
In a statement on its website, Eisai said it will discuss the matter with the regulators and review possibilities for resubmission. However, the company has said it is unable to say when it will resubmit its application as it does not know exactly what new data or clinical trials will be required.
Eisai and Pfizer, which sell the drug in selected countries outside Japan, won an application in the British High Court last month for a judicial review of what they see as NICE’s “controversial ruling” against donepezil for the treatment of patients with mild to moderate cases of the disease. The outcome of the review will apply to all three AChE inhibitors.
Aricept is the world’s best selling drug for the treatment of mild-to-moderate Alzheimer’s disease. It is currently approved to treat a severe form of the disease in the US, India, New Zealand and the Philippines. An application has also been submitted in Japan.
