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FDA Approves Kisunla to Slow Early Alzheimer’s Progression

5/3/2026

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Summary

FDA Approves Kisunla

The U.S. FDA approved Kisunla (donanemab) for adults with Alzheimer’s disease in 2024.
The drug is aimed at patients with mild cognitive impairment or mild dementia to slow disease progression.
John Hardy of University College London said better diagnosis and political will are needed, noting his 1990s amyloid research that enabled these antibodies.

Summary

Alzheimer's Association Issues

The Alzheimer’s Association issued its first clinical practice guideline in 2025 for blood-based biomarker tests in specialty care.
NIH reported the blood test detects Alzheimer’s disease with 88%-92% accuracy in symptomatic older adults, offering a cheaper alternative to brain scans and spinal-fluid analysis.
A 2025 Nature Communications study found p-tau217 and neurofilament light chain predict faster progression from mild cognitive impairment to dementia, enabling better risk assessment and trial selection.

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FDA Approves Kisunla

The U.S. FDA approved Kisunla (donanemab) for adults with Alzheimer’s disease in 2024.
The drug is aimed at patients with mild cognitive impairment or mild dementia to slow disease progression.
John Hardy of University College London said better diagnosis and political will are needed, noting his 1990s amyloid research that enabled these antibodies.

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