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FDA Approves New Alzheimer's Drug

By Edward Chen


The recent approval of the monoclonal antibody Kisunla (donanemab-azbt) by the FDA in July 2024 marks a breakthrough in the treatment of Alzheimer’s disease. Kisunla, developed by Eli Lilly, is designed for patients in the early stages of Alzheimer’s, such as those with mild cognitive impairment or mild dementia. The drug targets amyloid plaques —  protein build-ups in the brain associated with disease progression. Clinical trials have shown that Kisunla can slow cognitive and functional decline by up to 35%, making it a promising option for those with early-stage Alzheimer's​. The targeting of amyloid plaques is more precise than earlier treatments, which often focus on managing symptoms rather than directly addressing the underlying causes of the disease. Kisunla is administered through monthly intravenous (IV) infusions, offering a more convenient dosing schedule compared to other Alzheimer’s treatments like Donepezil and Rivastigmine, which require daily intake. However, similarly to other Alzheimer’s treatments before it, Kisunla carries some potential risks, such as amyloid-related imaging abnormalities (ARIA) including brain swelling or bleeding. Patients receiving Kisunla will need close monitoring, including multiple brain MRIs before and during treatment​. Nevertheless, these potential risks can still be a manageable tradeoff for the significant improvement—35%—in slowing down Alzheimer’s debilitating effects.


Accessibility Challenges: The drug’s annual cost is around $32,000, higher than other Alzheimer’s treatments like Donepezil, Galantamine, and Rivastigmine. While Kisunla is primarily covered under medical benefits, securing coverage through Medicare remains challenging due to current restrictions on this class of drugs, anti-amyloid antibodies. This specific type of drug faces coverage challenges due to ongoing questions about its clinical benefits and high costs per patient, making it difficult for Medicare to justify widespread coverage. Trying to access Kisunla might involve navigating insurance hurdles and ensuring patients meet specific qualifications​. If you are considering Kisunal for a loved one, the first step is to speak with your healthcare provider. They can help you determine whether the treatment is appropriate based on the stage of the disease and overall health. Your doctor can help guide you through the process of getting the drug, including discussing options for insurance and what monitoring will be necessary during treatment. It is also important to stay informed about Medicare policies, as adjustments may be made in the future to improve access to this new treatment. 


Although the drug is associated with some trade-offs, it represents a hopeful development in the fight against Alzheimer’s, providing patients and their families with a new tool to help manage the disease. While it is not a cure, Kisunla’s ability to slow the progression of Alzheimer’s offers a significant step forward, making early intervention and access to this treatment critical for those affected by the disease.



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