Kisunla (donanemab) is a monoclonal antibody developed by Eli Lilly and Company for the treatment of early symptomatic Alzheimer’s disease. Approved by the U.S. Food and Drug Administration (FDA) in July 2024, Kisunla represents a significant advancement in Alzheimer’s therapeutics, offering hope to patients and caregivers confronting this challenging condition.
Mechanism of Action
Kisunla targets amyloid-beta plaques in the brain, a hallmark of Alzheimer’s disease. By binding to these plaques, it facilitates their removal through microglial-mediated phagocytosis, potentially slowing disease progression.
Clinical Trials and Efficacy
The efficacy of Kisunla was demonstrated in the TRAILBLAZER-ALZ 2 study, a double-blind, placebo-controlled trial involving 1,736 participants with early symptomatic Alzheimer’s disease. Participants received either Kisunla or a placebo over 76 weeks. The study reported a statistically significant reduction in clinical decline among those treated with Kisunla, with a 35% slowing of decline in participants with low to medium tau levels and a 22% reduction in the overall population.
Administration and Dosage
Kisunla is administered as an intravenous infusion every four weeks. The recommended dosing regimen begins with 700 mg for the first three doses, followed by 1,400 mg for subsequent doses. Infusions typically last about 30 minutes. Notably, treatment may be discontinued once amyloid plaques are reduced to minimal levels, as confirmed by imaging, potentially reducing overall treatment duration and associated costs.
Safety and Side Effects
Common side effects of Kisunla include amyloid-related imaging abnormalities (ARIA), which may present as temporary brain swelling or small areas of bleeding, and headache. ARIA is often asymptomatic but can be serious; therefore, regular monitoring with MRI scans is recommended during treatment. Infusion-related reactions, such as flu-like symptoms, nausea, and changes in blood pressure, have also been reported. Patients with the ApoE ε4 genotype may have an increased risk of ARIA, and genetic testing is advised before initiating therapy.
Cost and Accessibility
The cost of Kisunla varies depending on treatment duration. A year of therapy is estimated at $32,000, with the potential for reduced costs if treatment is discontinued early due to sufficient amyloid clearance. Medicare and other insurance providers may cover a portion of the expenses, but out-of-pocket costs can vary. Patients are encouraged to consult with healthcare providers and insurers to understand coverage options.
Global Approvals
Following its FDA approval, Kisunla received approval from China’s National Medical Products Administration (NMPA) in December 2024, expanding its availability to patients in China.
Conclusion
Kisunla offers a promising treatment option for individuals with early symptomatic Alzheimer’s disease, potentially slowing cognitive and functional decline. However, patients and caregivers should carefully consider the benefits and risks, including side effects and financial implications, in consultation with healthcare professionals. Ongoing research and post-approval studies will continue to elucidate the long-term efficacy and safety profile of Kisunla in diverse patient populations.
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References
Eli Lilly and Company. (2024). Lilly’s Kisunla™ (donanemab-Azbt) approved by the FDA for the treatment of early symptomatic Alzheimer’s disease. Investor Relations. Retrieved from https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early
JAMA Network. (2024). Clinical trials demonstrate efficacy of Kisunla in slowing Alzheimer’s disease progression. JAMA. Retrieved from https://jamanetwork.com/journals/jama/fullarticle/2807533
U.S. Food and Drug Administration. (2024). FDA approves treatment for adults with early Alzheimer’s disease. FDA News. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease
Alzheimer’s Information. (2024). 5 things to know about Kisunla, the new Alzheimer’s drug. Alzheimer’s Research Center. Retrieved from https://www.alzinfo.org/articles/treatment/5-things-to-know-about-kisunla-the-new-alzheimers-drug/
MarketWatch. (2024). Lilly’s Kisunla gains FDA approval for early Alzheimer’s treatment. Retrieved from https://www.marketwatch.com/story/lilly-s-kisunla-donanemab-azbt-approved-by-the-fda-for-the-treatment-of-early-symptomatic-alzheimer-s-disease Yahoo Finance. (2024). Kisunla approved in China following FDA approval. Yahoo News. Retrieved from https://finance.yahoo.com/news/lillys-kisunla-donanemab-azbt-approved-010000142.html