Eisai Aricept (donepezil) shows no hepatotoxicity in Phase III trials; NDA filed March 29.

Executive Summary

EISAI ARICEPT FOR ALZHEIMER's SHOWS NO HEPATOTOXICITY, according to a company presentation of Phase III data at the American Academy of Neurology meeting in San Francisco March 26. Tokyo-based Eisai announced that Eisai America filed an NDA for Aricept (donepezil, E2020) on March 29. The filing is on schedule with the goal discussed by U.S. co-promotion partner Pfizer in 1994 ("The Pink Sheet" Dec. 5, 1994, T&G-5). Pfizer Exec VP Henry McKinnell said at a Financial Times conference in London that the NDA for the selective acetylcholinesterase inhibitor may get accelerated registration at FDA.