Eisai Files For Aricept In USA; Phase III Data
Eisai America, a subsidiary of Eisai of Japan, has filed a New Drug Application in the USA for Aricept (donepezil HCl; formerly E2020), its new acetylcholinesterase inhibitor for the treatment of Alzheimer's dementia.
If approved, Aricept will be comarketed by Eisai and partner Pfizer, under the terms of the strategic alliance signed by the two companies in November 1994. Aricept is the lead compound in this alliance, which focuses on the development of new drugs for Alzheimer's disease and other cognitive disorders.
The results of Phase III trials of Aricept were presented at the American College of Neurology meeting at the end of March. These data showed that once-daily administration of Aricept produced a statistically significant improvement in cognition and daily functioning scores for patients with mild-to-moderate disease. The drug was well-tolerated over the course of the study, with mainly transient gastrointestinal side effects reported which lasted only one or two days.
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