FDA Approves Eli Lilly’s Alzheimer’s Drug Kisunla for Early Symptoms

Eli Lilly has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approval of its Alzheimer’s disease (AD) treatment, Kisunla (donanemab-azbt). This new drug is designated for adults experiencing early-symptomatic Alzheimer's, specifically those in the mild cognitive impairment or mild dementia stages with verified amyloid pathology. Kisunla is administered as a once-monthly intravenous infusion.

Alzheimer’s disease is a progressively debilitating condition affecting about 6.9 million people in the U.S. It gradually erodes memory and cognitive abilities, eventually impairing a person's ability to perform simple daily tasks. The disease is ultimately fatal, making the pursuit of effective treatments particularly urgent.

Several clinical studies have identified that the removal of toxic amyloid plaques from the brain can significantly decelerate cognitive decline associated with Alzheimer's. In this context, Kisunla has shown promising results. Eli Lilly underscores that this treatment is unique as it is the first amyloid plaque-targeting therapy with evidence supporting the cessation of therapy once amyloid plaques are eliminated. This feature may lead to reduced treatment costs and fewer required infusions for patients.

The FDA's approval of Kisunla was influenced by a unanimous vote (11 to zero) from the agency's Peripheral and Central Nervous System Drug Advisory Committee. The committee concluded that the benefits of Kisunla outweigh its risks, based on trial data submitted by Lilly demonstrating the drug’s efficacy.

Key findings from the TRAILBLAZER-ALZ 2 study, a late-stage clinical trial, were instrumental in this decision. The study revealed that Kisunla slowed cognitive and functional decline by up to 35% compared to a placebo over an 18-month period in patients whose disease was less advanced. For the overall patient population, including those with higher tau levels, the reduction in decline was 22%. Moreover, among the studied groups, patients receiving Kisunla had up to a 39% lower risk of progressing to the next clinical stage of Alzheimer’s than those on placebo.

Anne White, the executive vice president and president of Lilly Neuroscience, highlighted the significance of these findings, stating, "Kisunla demonstrated very meaningful results for people with early symptomatic AD who urgently need effective treatment options." She emphasized the importance of early treatment and expressed Lilly's commitment to enhancing the detection and diagnosis of Alzheimer's through collaborative efforts.

This approval places Kisunla alongside another amyloid-targeting treatment, Eisai/Biogen's Leqembi (lecanemab), which is also sanctioned in the U.S. for early-stage Alzheimer's patients. The introduction of Kisunla offers a promising new option in the treatment landscape of Alzheimer's, providing hope for better management of this challenging neurodegenerative disease.