Eisai Provides Update On Aricept
Published: 02-Jul-2009
Plans to complete ongoing studies to provide important information on the therapeutic approach for Alzheimer’s disease
Eisai is currently focusing on three clinical development programs related to Aricept (donepezil hydrochloride), for Alzheimer’s disease.
Eisai has completed a phase-III study of 23mg donepezil sustained release (SR) in patients with moderate to severe Alzheimer’s disease. Donepezil SR is being developed to increase clinical benefits compared with currently marketed 10mg donepezil immediate release, raising the blood level of donepezil while maintaining favourable safety profile.
Eisai has filed a Proposed Pediatric Study Request (PPSR) with FDA in February, to evaluate the clinical benefits of donepezil in children with attention impairment following cancer treatment. Eisai received a notice from FDA that there were insufficient grounds to issue a Written Request to obtain pediatric exclusivity. Eisai plans to complete the ongoing studies to provide important information on this therapeutic approach for Alzheimer’s disease.
Based on the preliminary review of data from the phase-III study, Eisai plans to submit a New Drug Application with FDA in August or September this year.
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