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news.Eisai has been granted FDA approval for Aricept (donepezil hydrochloride) 23mg once daily tablet for the treatment of moderate-to-severe Alzheimer’s disease (AD).
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Eisai said that Aricept 23mg tablet offers dosing option for patients with moderate-to-severe AD for whom few treatments are available.
Aricept 23mg tablet has received approval based on data from a head-to-head study evaluating patients with moderate-to-severe AD, in which tje drug showed improvement in cognition compared to Aricept 10mg tablet.
The two co-primary endpoints examined in the study included the severe impairment battery (SIB), which measures cognition, and the Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC plus), which measures global function.
Eisai’s study that compared Aricept 23mg tablet to Aricept 10mg tablet showed improvement in SIB but did not achieve improvement in CIBIC plus.
Eisai said that based upon the submission of the Aricept 23mg tablet clinical trial data to the FDA, Aricept 23 mg tablet is expected to have three years of data exclusivity in the US.
Eisai stated that it will market Aricept 23mg tablet in the US with support from its Aricept co-promotion partner Pfizer.