FDA Approves New Alzheimer’s Drug, But Concerns Remain
The Food and Drug Administration (FDA) has granted approval to donanemab, a new drug for Alzheimer’s disease, offering hope for patients and families struggling with this devastating condition. Donanemab, to be sold under the brand name Kisunla by Eli Lilly, joins Leqembi, approved last year, as part of a novel class of treatments targeting amyloid plaques in the brain. Both drugs have shown modest success in slowing cognitive decline in the early stages of Alzheimer’s, but also carry significant safety risks, including brain swelling and bleeding.
Key Takeaways:
- Donanemab (Kisunla) is a new Alzheimer’s drug approved by the FDA. It is an intravenous infusion that targets amyloid plaques and has been shown to modestly slow cognitive decline in early stages of the disease.
- Like Leqembi, Donanemab has similar safety risks, including brain swelling and bleeding. However, Donanemab can be discontinued after amyloid is cleared, potentially reducing overall cost and risk.
- The approval of Donanemab and Leqembi represents an incremental step in the search for effective Alzheimer’s treatments, but many experts remain skeptical about their efficacy and believe the risks may outweigh the potential benefits.
- The focus on amyloid-targeting drugs has raised concerns that it might discourage research and investment in other potentially more effective Alzheimer’s treatments.
A New Class of Treatments:
Donanemab and Leqembi belong to a new class of drugs addressing the underlying biology of Alzheimer’s by targeting amyloid, a protein that begins to accumulate in the brain years before symptoms appear. These drugs represent a departure from past approaches that have focused on treating the symptoms of Alzheimer’s rather than its underlying cause.
Modest Improvements, Significant Risks:
Clinical trials have shown that both drugs can slow the progression of cognitive decline by several months. However, the benefit is modest, with some experts arguing that the improvements may not be noticeable to patients or their families. Additionally, both drugs carry significant safety risks, including brain swelling and bleeding. While most cases are mild or asymptomatic, some are serious and have even been linked to the deaths of patients.
A Differentiator: Discontinuation After Amyloid Clearance:
A key difference between Donanemab and Leqembi is that Donanemab can be discontinued after amyloid is cleared. This could reduce the overall cost and inconvenience of treatment, as well as the risk of side effects. However, the long-term effects of stopping and restarting treatment are still unknown and require further investigation.
Skepticism and Controversy:
Despite the FDA approval, the effectiveness of these drugs remains contentious. Some experts believe the risks outweigh the potential benefits, arguing that the data do not adequately demonstrate a clear correlation between amyloid removal and clinical improvement. Critics point to the lack of evidence that individuals who experience more amyloid removal show faster cognitive decline, a finding common in other diseases where successful treatments are linked to reduced viral load or other biological markers.
The Future of Alzheimer’s Treatment:
The approval of Donanemab and Leqembi highlights the need for continued research and development of new Alzheimer’s treatments. Dozens of other drugs are currently in clinical trials, targeting various aspects of the disease, including tau tangles, neuroinflammation, and other potential therapeutic targets.
While these new drugs represent a promising step forward, many in the field emphasize that they are just a starting point. It is crucial to continue investing in research and exploring alternative approaches to address the complex challenges of Alzheimer’s disease.
The Future of Hope:
Families facing Alzheimer’s are left with a difficult decision. Should they choose to take a chance on a treatment with potential benefits but also significant risks? The answer will vary depending on individual circumstances, risk tolerance, and the patient’s values. The debate over the value of these new drugs will continue, but one thing is certain: the search for effective Alzheimer’s treatments must continue with renewed vigor and a commitment to finding a truly impactful solution.
