FDA Approves Lilly's Kisunla for Early Symptomatic Alzheimer's Disease

AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved Kisunla (donanemab), a treatment developed by Eli Lilly and Company for early symptomatic Alzheimer's disease (AD). This includes patients with mild cognitive impairment (MCI) and those in the mild dementia stage of AD with confirmed amyloid pathology.

FDA Approves Lilly's Kisunla for Early Symptomatic Alzheimer's Disease

Kisunla, administered as a once-monthly 30-minute infusion, targets amyloid plaques in the brain. In its pivotal Phase 3 study, Kisunla demonstrated a significant slowdown in cognitive and functional decline by up to 35% compared to placebo over 18 months. Additionally, it reduced the risk of patients progressing to the next clinical stage of the disease by up to 39%.

One of Kisunla’s notable features is its treatment regimen based on the removal of amyloid plaques, which allows some patients to complete their course of treatment within 12 months. During the study, nearly half of the participants finished their treatment in this timeframe. On average, the treatment reduced amyloid plaques by 84% compared to the start of the study.

Amyloid is a naturally occurring protein that can form plaques in the brain, contributing to memory and cognitive issues associated with Alzheimer's disease. Kisunla helps reduce these amyloid plaques, thereby slowing down cognitive decline and helping patients maintain their ability to remember, plan, and manage daily activities.

The TRAILBLAZER-ALZ 2 Phase 3 study provided the basis for FDA approval. The study focused on two groups: patients with low to medium levels of tau protein, who were less advanced in their disease, and the overall population, which included participants with high tau levels. Both groups showed significant clinical improvements with Kisunla. For patients with lower tau levels, the drug slowed decline by 35% compared to placebo. In the broader study population, the slowdown was 22%.

Moreover, participants treated with Kisunla showed a 39% lower risk of advancing to the next clinical stage of Alzheimer’s compared to those on placebo. Kisunla significantly reduced amyloid plaques by 61% at six months, 80% at 12 months, and 84% at 18 months.

The study aimed to reduce amyloid plaques to levels detectable as negative on amyloid positron emission tomography (PET) scans. Participants who achieved these levels could switch to a placebo for the study's remainder.

Kisunla can cause amyloid-related imaging abnormalities (ARIA), detectable via MRI. ARIA might present as temporary brain swelling or small spots of bleeding and typically resolves over time. In rare cases, more significant bleeding can occur. Other potential side effects include serious allergic reactions during or shortly after infusion and headaches.

The cost of Kisunla treatment will vary depending on how quickly a patient achieves the desired reduction in amyloid plaques. According to the FDA's dosing guidelines, treatment can be stopped once minimal amyloid plaque levels are confirmed through PET scans. This limited-duration treatment regimen, combined with once-monthly infusions, could reduce overall treatment costs and the number of infusions needed compared to other therapies targeting amyloid plaques.

Coverage for Kisunla is available for eligible patients on Medicare under a National Coverage Determination with Coverage with Evidence Development. Additionally, broad coverage for amyloid PET scans has been available for Medicare patients since October 2023, ensuring that most eligible patients have coverage that minimizes their out-of-pocket expenses.

Lilly Support Services for Kisunla is a free program designed to help patients navigate their treatment options and manage their therapy effectively.

The list price is $32,000 for one year.