Eisai is denying claims that it withdrew a supplemental European application for its Aricept Alzheimer’s treatment because the National Institute for Health and Clinical Excellence is limiting use of the pill only to patients with moderate or severe symptoms.

The Japanese drug maker was asked by the European Medicines Agency to provide additional data showing that Aricept led to improvements in daily living activities in patients with severe Alzheimer’s. The agency has already accepted that Aricept improves cognition.

In a statement on its website, Eisai said it will discuss the matter with the Europeanregulators and review possibilities for resubmission. However, Eisai was unable to say when it will resubmit its application, because it’s not clear what new data or clinical trials will be required.

Eisai and Pfizer, which sell the drug in countries outside Japan, won an application in the British High Court last month for a judicial review of what they call NICE’s “controversial ruling” against Aricept for the treatment of patients with mild cases of the disease.

Source: PharmaTimes.
Further reading: Eisai statement (translation from Japanese web page).[tags]Aricept, Eisai, NICE, Pfizer[/tags]