The FDA has approved a new treatment for early symptomatic Alzheimer's Disease, including people that have mild cognitive impairment or mild dementia stage of disease.
So, what is the treatment, how does it work, and who may be eligible to receive it?
What is Kisunla?
Generally, treatments approved for Alzheimer's Disease fall into one of 2 categories:
Drugs that change disease progression
Drugs that mitigate disease symptoms
The newly approved treatment, Kisunla (donanemab, Eli Lilly), falls into the first category and aims to change disease progression. In a double-blind, placebo-controlled, parallel group study Kisunla (donanemab) showed a statistically significant reduction in clinical decline. Clinical decline was measured using a number of scales, and uses metrics such as memory, orientation, problem solving, personal care, and more. It is important to understand that Kisunla (donanemab) does not reverse Alzheimer's Disease or pre-existing memory issues, but rather prevents the issues from worsening.
How does it work?
Kisunla (donanemab) is a type of monoclonial antibody therapy. An antibody is a protein that specifically sticks to a another protein, called the antigen. Our body naturally has antibodies as part of our immune system and they seek out antigens, such as viruses, to facilitate their destruction (Figure 1). When monoclonical antibodies are used as a therapy, the antibody is made in a laboratory and created to bind to a target antigen. In the case of Kisunla (donanemab), the antibody targets a type of amyloid beta (Figure 1). Amyloid beta proteins contribute to the plaques that are a hallmark of Alzheimer's Disease. After 18 months of treatment, patients showed an average amyloid beta plaque decrease of 84%.
Figure 1. Examples of antibodies targeting antigens. Antibodies can be part of our body's natural immune system or produced in a laboratory. Figure created with Biorender.com
Who is eligible to receive Kisunla?
Kisunla (donanemab) is a once-per-month intravenous infusion that takes about 30 minutes. It is approved for use in patients with early symptomatic Alzheimer's Disease. This means your healthcare provider must determine your memory or thinking issues are due to early Alzheimer's Disease. Medicare is expected to provide coverage for the drug.
What are the possible risks?
In addition to potential allergic reactions, the most serious safety concern when receiving Kisunla (donanemab) is Amyloid-Related Imaging Abnormalities (ARIA). ARIA is characterized by bleeding or swelling in the brain. While mild cases of ARIA are very common and typically cause no symptoms or safety concerns, more serious cases can lead to symptoms such as headache, confusion, difficulty walking, or seizures. In rare cases, ARIA can be fatal. Your healthcare provider can assess your potential risk for ARIA and any safety concerns.
Sources:
Alzheimer’s Association. (2024, July 2). Alzheimer’s association welcomes U.S. FDA approval of Kisunla (Donanemab). Alzheimer’s Disease and Dementia. https://www.alz.org/news/2024/fda-approve-kisunla-donanemab-alzheimers-treatment
Alzheimer’s Association. (2024, March). FDA-Approved Treatments for Alzheimer’s. Alzheimer’s Association. https://www.alz.org/media/Documents/alzheimers-dementia-fda-approved-treatments-for-alzheimers-ts.pdf
Center for Drug Evaluation and Research. (2024, July 2). FDA approves treatment for adults with alzheimer’s disease. U.S. Food and Drug Administration. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease
Cleveland Clinic. (2021, November 16). Monoclonal antibodies: Definition & How Treatment Works. Cleveland Clinic. https://my.clevelandclinic.org/health/treatments/22246-monoclonal-antibodies
Diana Ernst, Rp. (2024, July 8). KISUNLA approved for early symptomatic alzheimer disease. Medical Professionals Reference . https://www.empr.com/home/news/kisunla-approved-for-early-symptomatic-alzheimer-disease/
Eli Lilly and Company. (2024, July 2). Lilly’s KISUNLATM (Donanemab-azbt) approved by the FDA for the treatment of early symptomatic alzheimer’s disease. Eli Lilly and Company Investors. https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early
Eli Lilly and Company. (2024, July). Once-monthly anti-amyloid treatment: KISUNLATM (Donanemab-azbt). Kisunla Lilly. https://kisunla.lilly.com/treatment#preparing-for-infusions
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