Eli Lilly's Alzheimer's Drug Label Update Gains FDA Approval

Eli Lilly's (LLY) stock rose 2% after the FDA approved an update to Kisunla's label for Alzheimer's treatment. The new monthly dosing regimen aims to reduce adverse events by up to 41%. The updated titration plan showed a significant reduction in amyloid-related imaging abnormalities with edema (ARIA-E) at 24 and 52 weeks, while maintaining similar levels of amyloid plaque clearance and reduction in P-tau217.

July 02, 2025

Eli Lilly and Company (LLY) saw its stock rise by 2% following the U.S. Food and Drug Administration's (FDA) approval of an updated label for Kisunla, a once-monthly amyloid-targeting therapy for early symptomatic Alzheimer's disease (AD). The new dosing regimen aims to reduce adverse events, particularly amyloid-related imaging abnormalities with edema (ARIA-E), by up to 41% [1].

The FDA approved the updated label, which includes a modified titration dosing schedule for Kisunla, based on results from the TRAILBLAZER-ALZ 6 study. The study showed that the new dosing regimen significantly lowered the incidence of ARIA-E at 24 and 52 weeks compared to the original dosing schedule, while maintaining similar levels of amyloid plaque clearance and reduction in P-tau217 [1].

The new dosing regimen involves a more gradual titration, shifting a single vial from the first dose to the third dose. This change resulted in lower rates of ARIA-E without compromising Kisunla's ability to reduce amyloid plaque or its once-monthly dosing potential [1].

The TRAILBLAZER-ALZ 6 study, which supports this label update, enrolled 843 participants ages 60-85 and found that the incidence of ARIA-E was 14% in patients receiving the modified titration compared to 24% for those receiving the original dosing regimen, a 41% lower relative risk at 24 weeks. At week 52, the incidence of ARIA-E was 16% in patients receiving the modified titration compared to 25% for those receiving the original dosing regimen, a 35% lower relative risk [1].

The new dosing strategy is a significant advancement for patients and their care teams, offering greater confidence in the safety of Kisunla while preserving its ability to reduce amyloid plaque [1].

References:
1. [1] https://investor.lilly.com/news-releases/news-release-details/fda-approves-updated-label-lillys-kisunla-donanemab-azbt-new