FDA Approves Lilly’s Kisunla for the Treatment of Early Symptomatic Alzheimer’s Disease

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The FDA has approved Eli Lilly’s Kisunla (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion) to treat adults with early symptomatic Alzheimer’s disease, including mild cognitive impairment and mild dementia with confirmed amyloid pathology. According to the company, Kisunla the first amyloid plaque-targeting therapy that allows for stopping treatment upon plaque removal, potentially reducing costs and infusion frequency. Approval was based on results from the Phase III TRAILBLAZER-ALZ 2 study.¹

"Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer's disease, who urgently need effective treatment options. We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis," said Anne White, EVP, president, Lilly Neuroscience, Eli Lilly and Company, in a press release. "Our deepest thanks to the patients and their loved ones for participating in our clinical programs and to Lilly scientists and collaborators persevering over decades of research. Each year, more and more people are at risk for this disease, and we are determined to make life better for them."

TRAILBLAZER-ALZ 2 was a double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic Alzheimer's disease (MCI or mild dementia due to Alzheimer's disease) with the presence of confirmed Alzheimer's disease neuropathology. Consisting of 1,736 patients across eight countries, participants were selected based on cognitive assessments in conjunction with evidence of Alzheimer's disease pathology. Additionally, the participants were divided into two groups over a period of 18 months. The first group consisted of individuals who were far less advanced in the disease, with the second consisting of the overall population.

Results found that in the first group, treatment with Kisunla demonstrated a clinical decline in disease for the less advanced group by 35% compared with placebo on the integrated Alzheimer's Disease Rating Scale (iADRS), measuring memory, thinking, and daily functioning. In the overall population group, treatment with Kisunla resulted in a disease decline of 22%. Patients treated with Kisunla had up to a 39% lower risk of progressing to the next clinical stage of disease than those taking placebo. Further, patients in the overall group experienced a reduction in amyloid plaques on average by 61% at six months, 80% at 12 months, and 84% at 18 months compared to the start of the study.

Reportedly, the treatment may cause amyloid-related imaging abnormalities (ARIA), typically detected via MRI, and can result in temporary brain swelling or small bleeding spots. Allergic reactions and headaches were also reported.¹

Current treatments for Alzheimer’s mainly target patients in the early or middle stages of Alzheimer’s. Current FDA-approved medications aimed at alleviating symptoms include brexpiprazole, donepezil, galantamine, memantine, and rivastigmine. Lecanemab is currently approved to treat mild Alzheimer’s.²

"This approval marks another step forward in evolving the standard of care for people living with Alzheimer's disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer's community. As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients," said Howard Fillit, MD, co-founder, chief science officer, Alzheimer's Drug Discovery Foundation (ADDF), in the press release. "Diagnosing and treating Alzheimer's sooner than we do today has the potential to meaningfully slow disease progression, giving patients invaluable time to maintain their independence for longer."

References

1. Lilly's Kisunla™ (donanemab-azbt) Approved by the FDA for the Treatment of Early Symptomatic Alzheimer's Disease. Lilly. July 2, 2024. Accessed July 2, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early

2. How Is Alzheimer's Disease Treated? NIH. Accessed July 2, 2024. https://www.nia.nih.gov/health/alzheimers-treatment/how-alzheimers-disease-treated#:~:text=Treating%20the%20symptoms%20of%20Alzheimer's,these%20medicines%20lose%20their%20effectiveness.