The recent recommendation by a panel of independent advisors to the Food and Drug Administration (FDA) in favor of Eli Lilly’s Alzheimer’s drug donanemab marks a significant step in addressing the unmet medical need for effective treatments for Alzheimer’s disease in the United States. The FDA typically follows the recommendations of its advisory panels, although it is not required to do so. If Eli Lilly’s donanemab clears for use, it will join Biogen and Eisai’s Leqembi as the second Alzheimer’s drug of its kind currently on the U.S. market. This recommendation highlights the urgent need for effective treatments for the more than 6 million Americans living with Alzheimer’s, which is the fifth-leading cause of death for adults over the age of 65.

The panel’s initial vote, where 11 committee members unanimously agreed that the available data shows donanemab’s effectiveness in treating Alzheimer’s patients in the early stages of the disease, is promising. However, concerns were raised regarding the lack of data on donanemab’s efficacy and safety in Black and Hispanic patients, among other groups. The second vote, where advisors unanimously agreed that the benefits of donanemab outweigh its risks, sheds light on the cautious optimism surrounding the approval of this drug. The FDA appears to be taking a more cautious approach in reviewing donanemab, especially after the controversy surrounding the approval of Aduhelm, another Alzheimer’s drug, from Biogen and Eisai.

Both Leqembi and donanemab represent significant milestones in Alzheimer’s treatment after decades of failed efforts to develop effective medications. These drugs, which are monoclonal antibodies targeting amyloid plaque in the brain, aim to slow the progression of the disease in patients in the early stages. However, it is important to note that these treatments are not cures and come with potential risks, such as brain swelling and bleeding, which can be severe and even fatal in some cases. The potential safety liabilities of donanemab, coupled with its less convenient administration through monthly intravenous infusions, may impact its commercial adoption relative to Leqembi.

An important consideration raised during the advisory panel meeting was the eligibility criteria for patients receiving donanemab. While Eli Lilly argued that testing for amyloid plaque should be sufficient for eligibility, some advisors suggested that requiring tau testing could restrict access to the drug. The trial data indicated that patients with low-to-medium levels of tau benefited more from the treatment, emphasizing the need for a thoughtful approach to patient eligibility criteria. Allowing patients to discontinue treatment once enough amyloid has been cleared could serve as a motivational factor for compliance with infusions and testing.

The potential risks associated with donanemab, such as brain swelling and bleeding, necessitate robust safety monitoring strategies. FDA staff indicated that if donanemab is approved, the drug’s label is expected to include a strong warning about these risks, particularly for individuals with specific genetic characteristics. Recommendations for MRIs to monitor for these side effects and other risk mitigation strategies will be essential in ensuring the safe use of the drug. The need for clear communication of these risks to healthcare providers and patients is paramount in promoting informed decision-making.

The FDA’s recommendation of Eli Lilly’s Alzheimer’s drug donanemab presents both opportunities and challenges in the landscape of Alzheimer’s treatment. The potential approval of donanemab could offer new hope for patients and caregivers grappling with the devastating impact of Alzheimer’s disease. However, careful consideration of efficacy, safety, patient eligibility criteria, and risk mitigation strategies will be crucial in ensuring the responsible and effective use of this treatment. As the FDA moves forward in its review process, continued vigilance and transparency will be essential in guiding the successful implementation of donanemab in clinical practice.

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