Alliance to FDA About Potential Donanemab Approval: ‘It’s Critical That We Get This Right’

The following statement was made today by Alliance President & CEO Sue Peschin, MHS, during the public comment portion of the U.S. Food & Drug Administration (FDA) meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS):

Hi everyone. I’m Sue Peschin, and I serve as president and CEO of the Alliance for Aging Research. While the Alliance receives funding from the sponsor and competitors, we don’t endorse any therapy or take positions on FDA approval of specific medical products.

In fact, the Alliance strongly believes that the FDA’s safety and effectiveness standards have remained steadfast. The FDA has consistently based decisions on sound science in support of its true public health mission. No other agency even comes close to having the FDA’s biomedical expertise.

When it comes to evaluation of risk/benefit for people living with early Alzheimer’s, the FDA’s senior career staff have made the right decisions, and carefully guarded their independence in a highly politicized environment. The adverse events related to donanemab are very low, and especially when compared to almost any oncology drug. Yet, because Alzheimer’s is a deadly disease primarily affecting older adults, clinical paternalism is common. For example, we’ve heard senior officials in the Medicare program recklessly refer to people living with early Alzheimer’s as “relatively healthy.” I wonder—would they say the same about someone living with a small malignant tumor?

Donamemab is part of the first wave of disease-modifying monoclonal antibody therapies for early Alzheimer’s. There is only one FDA-approved first-line therapeutic in this class currently available, but availability is highly rationed in Medicare and in the private payer market.

If the evidence and FDA recommendation support approval it would be a blessing for families to have a potential second treatment option. The community understands that donanemab is not curative but has shown promise in clinical trials in delaying the progression of the disease. This is of key importance to people living with early Alzheimer’s, where quality-of-life outcomes – such as overall cognition, personality, and the ability to care for oneself – are the ones that matter most. We encourage everyone here to recognize that people living with early Alzheimer’s and their families are more than capable of assessing risk/benefit with their clinicians, and to mutually decide the right treatment decision for them.

On a personal note, my aunt is 62 years old and went through evaluation for Leqembi but did not qualify due to microhemorrhages. My 83-year-old mom is further along, and I care for her on the weekends. These women are my heart. Neither of them will qualify for this drug. I am here on the Alliance’s behalf and their behalf to say—it’s critical that we get this right.  

Unfortunately, the public’s trust in science and government has seen better days. How we express ourselves both in agreement and disagreement shapes narratives and can contribute to misinformation.

To the Advisory Committee, consider how your dialogue today will help or harm the public’s trust in science and the FDA. Please serve as true, constructive advisors to the FDA’s impartial, rigorous, and expert review.

Thank you.