By Fineline Cube 
US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) has announced that the US Food and Drug Administration (FDA) has approved a label update for its monthly amyloid-targeting therapy, Kisunla (donanemab). The updated labeling includes a new recommended titration dosing schedule designed to enhance safety and efficacy for adults with early symptomatic Alzheimer’s disease (AD), including those with mild cognitive impairment (MCI) or mild dementia-stage AD.
Approval Details
The revised dosing regimen replaces the original schedule of 700 mg for the first three months, followed by 1400 mg monthly. The new titration approach begins with a gradual dose escalation: 350 mg in Month 1, 700 mg in Month 2, 1050 mg in Month 3, and then 1400 mg monthly thereafter. This modification aims to reduce the risk of amyloid-related imaging abnormalities with edema/effusion (ARIA-E), a known side effect associated with amyloid-targeting therapies.
Clinical Evidence from TRAILBLAZER-ALZ 6 Study
The updated dosing schedule was supported by data from the TRAILBLAZER-ALZ 6 study, which demonstrated that the new regimen significantly reduced the incidence of ARIA-E at both 24 and 52 weeks compared to the original dosing schedule. Importantly, this reduction in safety risks did not compromise therapeutic efficacy, reinforcing Kisunla’s potential as a safer and effective treatment option for early-stage Alzheimer’s disease.
Donanemab’s Mechanism of Action
Kisunla (donanemab) is a monthly monoclonal antibody designed to target amyloid plaques in the brain, which are a hallmark of Alzheimer’s disease. By binding to aggregated amyloid-beta proteins, donanemab facilitates their removal from the brain, potentially slowing disease progression and improving cognitive outcomes for patients with early symptomatic AD.
Significance of the Label Update
The FDA’s approval of the updated dosing schedule represents a significant step forward in optimizing Kisunla’s safety profile while maintaining its therapeutic benefits. This development underscores Eli Lilly’s commitment to advancing innovative treatments for Alzheimer’s disease and improving outcomes for patients with early-stage symptoms.-Fineline Info & Tech