FDA Advisory Committee Unanimously Endorses Donanemab for Full Approval

Washington, DC (June 10, 2024) — An advisory committee convened by the Food and Drug Administration (FDA) to evaluate Donanemab unanimously endorsed the drug for full FDA approval on Monday. Donanemab is a disease modifying drug that slows the progression of Alzheimer’s disease by targeting amyloid plaque in the brain. George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s, issued the following statement in response to this positive development:

“We are grateful to the advisory committee for its endorsement of this promising treatment. If approved by the FDA, Donanemab would be the second drug on the market to help people in the early stages of Alzheimer’s live a better quality of life for a longer period of time, while providing patients and their doctors with another option for their treatment plans.”

Vradenburg spoke during the public comment portion of Monday’s meeting. Below are his remarks as prepared for delivery:

Thank you for this opportunity to provide comments on the Committee’s work.

I am George Vradenburg, Executive Chairman and Co-Founder of UsAgainstAlzheimer’s. I have no personal financial disclosures.  I am driven to my advocacy because I have lost three generations of my family to this damned disease. My organization is a national nonprofit that receives programmatic support from Lilly as well as thousands of other donors. 

At the risk of stating the obvious, Alzheimer’s is a devastating, progressive, and ultimately fatal disease and represents an unmet medical need of historic proportions.

Treatments that slow this relentless trajectory at its early stage —before people lose their independence—are highly valued as that slowing means more time with families, with friends, with life … and more time being alive to even more powerful medicines in the future. 

The consistent evidence across different clinical measures in the donanemab trials demonstrate that this medicine delays functional decline --which we know from our own peer-reviewed published studies is what patients want and find meaningful.

Additionally, having a second disease-modifying therapy for patients and their doctors to consider, will, in my view, dramatically accelerate the comprehensive health system adjustments patients so badly need to create a world where Alzheimer’s is a treatable disease and not an inevitable, fatal consequence of aging.

I understand that an issue before this Committee is whether there should be limitations on access to this amyloid-lowering product based on the presence or levels of tau.  While you appropriately will deliver your best scientific advice in this question, I urge you to consider the severe practical restrictions on patient access to this drug should such limitations be imposed, given the paucity of available tau PET scans in most of the country.

One additional note: there was inadequate representation in these trials of minoritized, rural, and low resource populations. While not a question before you today, the patient community, and the field more generally, must — and, in my view, will — tackle this issue with intentionality. 

This Committee should act with clarity and urgency on this massive unmet need, with confidence that people living with Alzheimer’s will find the delay in progression shown by this drug to be meaningful and important.  

Patients and their families, informed by their physicians regarding the benefits and risks of donanemab, should be permitted the autonomy and personal agency to make the choices best suited to their own individual preferences and needs in deciding whether to use this important new medicine.

Thank you.  

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About UsAgainstAlzheimer’s
UsAgainstAlzheimer’s is engaged in a relentless pursuit to end Alzheimer’s, the sixth leading killer in America. Our work centers on prevention, early detection and diagnosis, and equal access to treatments regardless of gender, race, or ethnicity. To achieve our mission, we give voice to patients and caregivers while partnering with government, scientists, the private sector, and allied organizations -- the people who put the “Us” in UsAgainstAlzheimer’s.