Lilly Alzheimer's Drug Receives FDA Approval for Gradual Dosing.

The US FDA has approved Eli Lilly's Alzheimer's drug with a gradual dosing regimen. Biogen is a leader in therapeutic products, with net sales from medicine sales, royalties, and other sources such as partnership agreements.

The U.S. Food and Drug Administration (FDA) has approved an updated label for Eli Lilly and Company's (NYSE: LLY) Alzheimer's drug, Kisunla (donanemab-azbt), which includes a new recommended titration dosing schedule for early symptomatic Alzheimer's disease. The approval, announced on July 9, 2025, aims to enhance the safety profile of the treatment while maintaining its efficacy.

The new dosing regimen involves a more gradual titration, which significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) compared to the original dosing schedule. The TRAILBLAZER-ALZ 6 study, a Phase 3b clinical trial, demonstrated that the modified titration schedule reduced ARIA-E by 41% at 24 weeks and by 35% at 52 weeks [1].

This update is a significant advancement in Alzheimer's disease treatment, offering healthcare professionals a safer option for their patients. The new dosing regimen shifts a single vial from the first dose to the third dose, delivering the same amount of Kisunla by week 24. This modification resulted in lower ARIA-E rates without compromising the drug's ability to reduce amyloid plaque or its once-monthly dosing potential [1].

Kisunla, an amyloid-targeting therapy, is designed to treat adults with early symptomatic Alzheimer's disease, including those with mild cognitive impairment (MCI) and mild dementia. The drug was initially approved by the FDA in July 2024 based on the TRAILBLAZER-ALZ 2 Phase 3 clinical trial data [1].

Lilly's commitment to patient safety and the advancement of Alzheimer's disease treatment is evident in this label update. The company continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3 and TRAILBLAZER-ALZ 5, to further reduce the risk of progression to symptomatic AD [1].

References:
[1] https://www.streetinsider.com/PRNewswire/FDA+approves+updated+label+for+Lillys+Kisunla+%28donanemab-azbt%29+with+new+dosing+in+early+symptomatic+Alzheimers+disease/25030783.html