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A breakthrough treatment for Alzheimer’s was approved by U.S. regulators on July 3, 2024, marking a critical milestone in the battle against this devastating disease. The promising results of Kisunla (donanemab) have brought hope to millions of patients and their families.
A revolutionary treatment against amyloid deposits
Kisunla, developed by Eli Lilly, is an immunotherapy that specifically targets beta-amyloid deposits, a key feature of Alzheimer’s disease. In July 2023, Eli Lilly published the results of its phase 3 trial, revealing a dramatic 84% reduction in amyloid burden after 18 months of treatment.
Additionally, patients showed a 35% slowing of cognitive and functional decline and a 39% reduction in the risk of progression to a more advanced clinical stage of the disease. Finally, patients who had sufficiently low levels of amyloid deposits were able to stop treatment.
Encouraging results but side effects to watch out for
Although the results are encouraging, it is crucial to monitor the potential side effects of this treatment. ARIA (amyloid-related imaging abnormalities), including cerebral hemorrhage and edema, are serious complications observed in some patients. Allergic reactions and migraines have also been reported.
Therefore, rigorous monitoring of at-risk patients is essential.
A high cost but potentially covered by Medicare
Kisunla will sell for $32,000 for a 12-month treatment in the United States, with possible Medicare coverage, making the treatment accessible to more patients. The news is welcomed with optimism by Alzheimer’s organizations, such as the Fondation Vaincre Alzheimer, who see the approval as significant progress.
A new era for Alzheimer’s treatments
The FDA approval of Kisunla follows that of Leqembi, another anti-amyloid immunotherapy already marketed in several countries. The EMA (European Medicines Agency) decision on these treatments is still pending.
Despite these advances, Alzheimer’s disease remains complex and multifactorial. New treatments represent a step forward, but they are not enough to completely stop the progression of the disease. Research continues to develop other therapies targeting different biological mechanisms of the disease.
“The FDA approval of Kisunla marks another important milestone in our ongoing fight against Alzheimer’s disease. This progress brings renewed hope to millions of families affected by this devastating disease. Given the complexity of this disease, these treatments alone are not enough to stop the progression of the disease. We must therefore continue to support and champion innovative research together, to open new therapeutic avenues and accelerate the arrival of new treatments.” declares Maï Panchal, General and Scientific Director of the Vaincre Alzheimer Foundation.
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