UsAgainstAlzheimer’s Statement on FDA Complete Response Letter for Donanemab

UsAgainstAlzheimer’s Statement on FDA Complete Response Letter for Donanemab

 

Washington, D.C. (January 19, 2023) – UsAgainstAlzheimer’s chief operating officer Russ Paulsen issued the following statement regarding the complete response letter from the Food and Drug Administration regarding accelerated approval of donanemab:

“While we are disappointed this treatment won’t be made available to patients sooner, the reason why is encouraging: donanemab worked too well to meet the criteria required by the FDA. The FDA requires a minimum of 100 patients to be on the drug for at least twelve months but, due to donanemab’s quick action in some patients, many were able to stop treatment in as little as six months. We are very encouraged by that and look forward to learning even more about donanemab’s effectiveness when Lilly releases its Phase 3 trial data later this year in advance of its application for traditional FDA approval.”

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About UsAgainstAlzheimer’s

UsAgainstAlzheimer’s exists to conquer Alzheimer’s disease. We take on the toughest problems; bring all of “Us” together to break down barriers; advocate for research that will speed treatments to market; and drive changes that matter most to people living with the disease. We will not rest until brain-span equals lifespan - for everyone.