FDA approves donanemab to treat early Alzheimer’s: What experts think
The FDA’s approval of donanemab (to be marketed under the brand name Kisunla) is a landmark event in the treatment of Alzheimer’s disease. Here is a comprehensive breakdown of what the experts are saying, reflecting the consensus, the hope, and the caution.
The Headline: A New Era of Treatment
The FDA has approved donanemab, a monoclonal antibody therapy, for the treatment of early symptomatic Alzheimer’s disease. This includes patients with mild cognitive impairment (MCI) or mild dementia stages of the disease, who have a confirmed presence of amyloid plaques in the brain.
Donanemab joins lecanemab (Leqembi) as the second drug in its class to be fully approved in the U.S. that changes the underlying course of the disease by clearing amyloid.
What the Experts Are Saying: A Spectrum of Opinions
The expert reaction is broadly positive but nuanced, characterized by “cautious optimism.” Here’s a breakdown of their key points:
1. The Hopeful and Encouraged View: “A Turning Point”
- It validates the Amyloid Hypothesis: For decades, the theory that clearing amyloid-beta plaques could slow Alzheimer’s was just that—a theory. The success of donanemab and lecanemab proves that targeting amyloid is a viable therapeutic strategy. Experts see this as a definitive turning point after many past failures.
- Meaningful Slowing of Decline: In the pivotal clinical trial, donanemab demonstrated a significant slowing of clinical decline by about 35% over 18 months compared to a placebo. For patients and families, this translates to more time to live independently, participate in family events, and manage personal finances.
- A Dosing Endpoint: A unique and patient-friendly feature of donanemab is that treatment can be stopped once a patient’s amyloid plaques are reduced to a very low level. This “treat-to-clear” protocol means patients aren’t necessarily on the drug for life, potentially reducing long-term costs and side effects.
Expert Quote (Representative): “This is the decade where we go from theory to practice. We now have tools that can meaningfully change the trajectory of this disease. It’s not a cure, but it’s the most important breakthrough we’ve ever had.” – Dr. Ronald Petersen, Director of the Mayo Clinic Alzheimer’s Disease Research Center.
2. The Cautious and Pragmatic View: “A Step, Not a Finish Line”
- Significant Risks and Side Effects: The most serious side effects are Amyloid-Related Imaging Abnormalities (ARIA). ARIA can manifest as brain swelling (ARIA-E) or micro-bleeds (ARIA-H). While often asymptomatic and detectable only on MRI, it can be serious and, in rare cases, fatal. Expert consensus is that these risks must be carefully managed.
- Modest Benefit for a High Cost: The 35% slowing is statistically significant, but experts caution that the absolute benefit for an individual patient may feel modest. They weigh this against the very high cost of the drug (Eli Lilly has set a list price of $32,000 per year for donanemab, similar to Leqembi) and the extensive healthcare infrastructure required.
- The Infrastructure Challenge: Administering these drugs is not simple. It requires:
- Accurate Early Diagnosis: Confirming early Alzheimer’s with PET scans or cerebrospinal fluid tests.
- Genetic Testing: For ApoE ε4 status, as carriers have a higher risk of ARIA.
- Specialized Infusion Centers: For monthly IV treatments.
- Frequent MRI Monitoring: To check for ARIA.
Many healthcare systems, especially in rural or underserved areas, are not yet equipped for this.
Expert Quote (Representative): “This is a qualified victory. The benefit is real but incremental, and the risks are substantial. The challenge now is to build a system that can deliver these drugs safely, equitably, and only to those who are likely to benefit.” – Dr. Jason Karlawish, Co-Director of the Penn Memory Center.
3. The Future-Oriented View: “A Foundation to Build Upon”
- Combination Therapies are the Future: Experts see donanemab not as the end, but as a foundational treatment. The next logical step is to combine amyloid-clearing drugs with therapies that target tau (the other key Alzheimer’s protein) and drugs that protect nerve cells. Donanemab is the “first piece of the puzzle.”
- Earlier Intervention is Key: The trials show that the earlier you treat, the greater the benefit. This is fueling a massive push for better, cheaper, and more accessible blood tests (e.g., p-tau217) to identify at-risk individuals long before significant symptoms appear.
- Prevention on the Horizon: The ultimate goal is to use these drugs in the pre-symptomatic stage to prevent the disease altogether. Trials are already underway in this direction.
Expert Quote (Representative): “Donanemab is a critical proof-of-concept. It tells us we’re on the right path. Now, we need to build on this success by targeting other aspects of the disease and moving treatment earlier, ultimately aiming for prevention.” – Dr. Reisa Sperling, Director of the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital.
Connecting Back to the Predictive Tool
This approval makes the predictive tool for Alzheimer’s risk mentioned in the previous article even more relevant.
- Early Identification is Everything: With an effective treatment now available, identifying people at high risk for memory decline before it becomes significant is crucial. The predictive tool (using APOE, MMSE, and subjective complaints) could be a first-line, low-cost method to flag individuals who should then undergo more definitive testing (amyloid PET or blood tests) to see if they are candidates for donanemab.
- A Pathway to Treatment: The workflow becomes: Risk Calculator -> Confirmatory Amyloid Test -> Donanemab Treatment. This creates a proactive pathway from risk assessment to intervention.
Conclusion: A Watershed Moment with Work Ahead
The consensus among experts is clear: The FDA’s approval of donanemab is a watershed moment for the Alzheimer’s field. It provides a new, effective treatment option that meaningfully slows the disease.
However, it comes with significant challenges regarding safety, cost, and healthcare delivery. The excitement is tempered by a sober understanding of the work required to integrate this therapy into real-world practice. For patients and families, it represents a new, tangible hope—a chance to buy more quality time in the early stages of a devastating disease.
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