Tuesday, July 16, 2024

Alzheimer’s Treatment Advance: FDA Approves Lilly’s Kisunla for Early Symptomatic Stages

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Alzheimer’s disease treatment has advanced with the U.S. Food and Drug Administration’s (FDA) approval of Eli Lilly’s Kisunla (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion) for adults with early symptomatic stages, including mild cognitive impairment and mild dementia with confirmed amyloid pathology. Kisunla stands out as the first amyloid plaque-targeting therapy that permits stopping treatment upon plaque removal, potentially reducing costs and infusion frequency. This approval was based on results from the Phase III TRAILBLAZER-ALZ 2 study.

“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.”

Alzheimer’s Treatment Study: TRAILBLAZER-ALZ 2 Evaluates Donanemab in Early Symptomatic Stages Across 1,736 Patients

TRAILBLAZER-ALZ 2 is a double-blind, placebo-controlled study designed to evaluate the safety and efficacy of donanemab in participants with early symptomatic Alzheimer’s disease, including mild cognitive impairment or mild dementia due to Alzheimer’s disease, with confirmed Alzheimer’s pathology. The study enrolled 1,736 patients across eight countries, selected based on cognitive assessments and evidence of Alzheimer’s disease pathology. Participants were divided into two groups over 18 months: one group consisted of individuals less advanced in the disease, while the second group included the overall population.

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

Alzheimer's

Alzheimer’s Treatment Side Effects: Amyloid-Related Imaging Abnormalities and Other Reactions Reported in Donanemab Therapy

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

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

“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 and 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.”

Kisunla’s approval represents a significant advancement in Alzheimer’s treatment, offering a new approach that targets amyloid plaques and provides an option to discontinue therapy once plaques are removed. This can potentially lessen the financial burden and inconvenience associated with ongoing infusions. The promising results from the TRAILBLAZER-ALZ 2 study highlight the efficacy of Kisunla in slowing disease progression and improving patient outcomes, particularly when administered early in the disease course. As researchers and healthcare professionals continue to work on improving early detection and diagnosis, Kisunla may play a crucial role in transforming the treatment landscape for Alzheimer’s disease and enhancing the quality of life for patients and their families.

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Resource: Lilly, July 02, 2024

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