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pivotal APOLLOE4 Phase III trialHome
•86% Informative
ALZ-801, also called valiltramiprosate, is under study in the Phase III APOLLOE4 trial.
The double-blind, randomized trial is set to be completed in mid-2024 , with Alzheon planning to submit a new drug application ( NDA ) before year’s end .
The company plans to fund the completion of a pivotal Phase III trial and regulatory filings later this year .
Eli Lilly has been pursuing FDA approval for its amyloid plaque-targeting therapy donanemab.
The FDA has final say, though it typically follows the recommendations of its advisory committees.
The companies to date have fared better with Leqembi than with their earlier controversial yet approved Alzheimer’s disease drug Aduhelm (aducanumab-avwa).
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