July 2, 2024 – The U.S. Food and Drug Administration (FDA) has approved donanemab, a groundbreaking treatment for Alzheimer’s disease. Branded as Kisunla™ (pronounced kih-SUHN-lah) by Eli Lilly, donanemab is an amyloid plaque-targeting therapy for persons living with mild cognitive impairment (MCI) or in the mild dementia stage of Alzheimer’s disease with confirmed amyloid pathology.
“This approval offers new hope to patients and families, as donanemab has shown promising results in slowing cognitive decline in early symptomatic stages of Alzheimer’s,” said Dr. Joel Salinas, Isaac Health’s Chief Medical Officer. “It is important to note that the treatment is specifically approved for those with confirmed Alzheimer’s pathology and mild cognitive impairment or mild dementia. This ensures that the therapy is targeted to those most likely to benefit.”
Drugmaker Eli Lilly has shared that the drug will be available within weeks after the FDA approval.
What does donanemab do?
Donanemab is an anti-amyloid monoclonal antibody infusion administered every four weeks that is used to treat Alzheimer’s disease. It works by targeting the amyloid plaques in the brain – which are linked to Alzheimer’s disease – by binding to and removing them.
In the TRAILBLAZER-ALZ 2 Phase 3 study conducted last year, participants in the early stages of Alzheimer’s disease showed the most significant benefits from donanemab. The trial analyzed participants over 18 months and divided them into two groups: those who were less advanced in the disease (based on low to medium levels of tau protein on tau PET imaging) and the overall study population (inclusive of those with higher levels of tau). Key findings include:
- Treatment with donanemab markedly slowed clinical decline in both groups.
- For those in the less advanced group, donanemab reduced decline by 35% compared to placebo on the integrated Alzheimer’s Disease Rating Scale (iADRS), which assesses memory, thinking, and daily functioning.
- In the overall population, the treatment response was also statistically significant at 22% on the iADRS.
- Participants treated with donanemab had up to a 39% lower risk of progressing to the next clinical stage of the disease compared to those on placebo.
Donanemab can cause serious side effects, including amyloid-related imaging abnormalities (ARIA), certain types of allergic reactions, and headaches. Allergic reactions caused by donanemab typically occur during the infusion or 30 minutes after the infusion. These side effects can result in life-threatening events, so patients must be monitored for at least 30 minutes after their infusion.
For more information about the drug and eligibility requirements, visit your healthcare provider or reach out to a specialist at Isaac Health’s clinic.
Giving patients and clinicians a choice
Donanemab is the second Alzheimer’s drug of its kind to receive FDA approval, with the first such drug being lecanemab (brand name Leqembi – pronounced “leh-KEM-bee”), which was approved last year. “Having multiple treatment options is the kind of advancement we’ve all been waiting for,” said Dr. Joanne Pike, president and CEO of the Alzheimer’s Association.
At Isaac Health, we are committed to helping patients receive clinical guideline-recommended and evidence-based care for Alzheimer’s disease and related disorders. For more information on how Isaac Health can help you or a loved one, please visit our website at www.myisaachealth.com.
