US FDA Approves Gradual Dosing for Lilly Alzheimer’s Drug

Advanced | July 16, 2025

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A Safer Approach to Alzheimer’s Treatment

Why the FDA Approves Gradual Alzheimer’s Drug Dosing

In a significant development for Alzheimer’s patients, the U.S. Food and Drug Administration (FDA) has approved a modified, gradual dosing schedule for Eli Lilly’s Alzheimer’s disease drug, Kisunla (donanemab-azbt). This FDA-approved approach to gradual Alzheimer’s drug dosing aims to considerably lower the risk of a serious side effect: amyloid-related imaging abnormalities with edema/effusion (ARIA-E), a form of brain swelling.

Making Treatment Safer Without Sacrificing Results

This change is designed to make the treatment safer without reducing its effectiveness in clearing amyloid plaques, a hallmark of Alzheimer’s. This approval, granted on July 9, 2025, highlights the FDA’s ongoing efforts to support safer long-term use of Alzheimer’s medications through more gradual and personalized treatment approaches.

Background on Kisunla and Initial Concerns

Kisunla, which received its initial FDA approval in July 2024, was the third drug to be cleared for slowing the progression of Alzheimer’s by targeting these harmful amyloid beta plaques. The original dosing regimen began with a higher dose of 700 mg intravenously for the first three months, followed by 1400 mg monthly thereafter. However, ARIA-E, while often asymptomatic, has been a significant concern, contributing to reluctance among physicians to prescribe the drug and even preventing its use in certain countries.

The Science Behind the Shift

Results from Clinical Trials

To address these safety concerns, the new protocol introduces a more gradual increase in dosage. Patients will now receive a single 350 mg vial for their first monthly infusion, followed by two vials for the second month, three for the third, and then the full four vials (1400 mg) from the fourth month onward. Crucially, this ensures that patients still receive the same total dose by week 24, maintaining the drug’s therapeutic effect. This adjustment reflects the FDA’s focus on minimizing health risks through gradual Alzheimer’s drug dosing.

This modified schedule is based on compelling data from the Phase 3b clinical trial, TRAILBLAZER-ALZ 6. The study demonstrated a remarkable 41% reduction in the incidence of ARIA-E at 24 weeks, decreasing from 24% with the original regimen to just 14% with the gradual dosing. Even at 52 weeks, the reduction remained significant at 35% (16% versus 25%). Importantly, the trial confirmed that this phased approach did not diminish Kisunla’s effectiveness, with patients still achieving an average of 67% reduction in amyloid plaques from baseline.

Market Impact and Ongoing Research

Despite Kisunla’s proven potency in clearing plaques, its sales had been modest, reaching only \$21 million in the first quarter of 2025. Safety concerns and the complexities of diagnosing and administering the treatment contributed to the slow sales. Eli Lilly expects the updated dosing schedule to significantly enhance the drug’s safety profile, which should help healthcare professionals feel more confident in evaluating and prescribing Kisunla as an appropriate treatment option for their patients. While Kisunla, which competes with drugs like Eisai and Biogen’s Leqembi, still carries a boxed safety warning for ARIA-E and ARIA-H (brain bleeding), Eli Lilly continues to research donanemab in ongoing clinical trials, including TRAILBLAZER-ALZ 3 and TRAILBLAZER-ALZ 5, to investigate its potential in slowing disease progression further.

This case highlights why FDA approval of gradual Alzheimer’s drug dosing can make a meaningful difference in public perception and adoption of new treatments.

Vocabulary

Dosing schedule (noun): The plan or timetable for administering doses of a drug.
- Example: “The new dosing schedule for Kisunla aims to reduce side effects.”
Efficacy (noun): The ability to produce a desired or intended result; effectiveness.
- Example: “The study confirmed the drug’s efficacy in reducing amyloid plaques.”
Compromising (verb): Causing damage to or making vulnerable; weakening.
- Example: “The modified regimen was designed to enhance safety without compromising efficacy.”
Reluctance (noun): Unwillingness or hesitation to do something.
- Example: “Physician reluctance in prescribing the drug was partly due to safety concerns.”
Regimen (noun): A prescribed course of medical treatment, diet, or exercise for the promotion or restoration of health.
- Example: “The original dosing regimen involved higher initial doses.”
Incidence (noun): The occurrence, rate, or frequency of a disease, crime, or something else undesirable.
- Example: “The trial showed a significant reduction in the incidence of brain swelling.”
Diminish (verb): Make or become less.
- Example: “The gradual dosing did not diminish the drug’s effectiveness.”
Potency (noun): The power of something to influence or make an impression; the strength of a drug.
- Example: “Despite its potency, the drug’s sales were modest.”
Administering (verb): Dispensing or applying (a remedy or drug).
- Example: “Healthcare professionals will find the new schedule easier for administering the treatment.”
Asymptomatic (adjective): Showing no symptoms of disease.
- Example: “Brain swelling can often be asymptomatic, making it difficult to detect without imaging.”

Discussion Questions (About the Article)

What was the main reason the FDA approved a new dosing schedule for Kisunla?
How does the new dosing schedule for Kisunla differ from the original one?
What significant positive outcome was observed in the TRAILBLAZER-ALZ 6 study regarding the modified dosing?
Why do you think the initial sales of Kisunla were modest despite its effectiveness?
What are ARIA-E and ARIA-H, and why are they a concern for Alzheimer’s drugs like Kisunla?

Discussion Questions (About the Topic)

What are some of the challenges involved in developing new treatments for complex diseases like Alzheimer’s?
How important do you think it is for pharmaceutical companies to address side effects, even if a drug is effective?
Imagine you are a doctor. How would an improved safety profile influence your decision to prescribe a new drug?
Do you think news like this can impact public perception of drug safety and trust in pharmaceutical companies? Why or why not?
What role do clinical trials play in bringing new medications to market and ensuring their safety?

Related Idiom

Break new ground

Meaning: To make a new discovery or develop a new method.
Example: “Researchers are always striving to break new ground in the fight against diseases like Alzheimer’s.”

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This article was inspired by: Reuters | July 9, 2025

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Tags: Alzheimer’s disease, FDA approval, Drug safety, Gradual dosing, Amyloid plaques