A Major Breakthrough in Alzheimer's Treatment: Kisunla® Approved

After decades of intensive research, a groundbreaking treatment for Alzheimer's disease has arrived. In July 2024, the U.S. Food and Drug Administration (FDA) approved Kisunla® (donanemab), an innovative immunotherapy that represents a significant step forward in the fight against this devastating condition. This marks the dawn of disease-modifying treatments that target the biological causes of Alzheimer's rather than just managing symptoms.

What Makes Kisunla® Revolutionary?

Kisunla® is a monoclonal antibody that specifically targets and removes amyloid-beta plaques in the brain—one of the hallmark features of Alzheimer's disease. Unlike previous medications that only addressed symptoms, this therapy actually slows the progression of cognitive and functional decline in patients with early-stage Alzheimer's disease.

Clinical trials have shown impressive results:

• 22% slower decline in cognitive function over 18 months compared to placebo

• Up to 35% improvement in patients with less advanced disease pathology

• 37% reduced risk of progressing to the next clinical stage of the disease

What this means in practical terms: patients experience less severe memory and thinking problems, maintain their ability to perform daily activities longer, and require less intensive caregiver support.

How It Works

Kisunla® is administered as an intravenous infusion once every four weeks. The treatment is intended for adults with mild cognitive impairment (MCI) or mild dementia stage of Alzheimer's disease who have confirmed amyloid pathology. The drug works by binding to the insoluble pyroglutamate form of amyloid-beta found in brain plaques and promoting their removal through microglial-mediated phagocytosis—essentially, the brain's own cleanup system.

In July 2025, the FDA approved an updated dosing schedule that significantly reduces the risk of amyloid-related imaging abnormalities (ARIA), particularly brain swelling, while maintaining the drug's effectiveness at clearing amyloid plaques.

Long-Term Benefits

Recent data presented at the 2025 Alzheimer's Association International Conference (AAIC) revealed that the benefits of donanemab extend well beyond the initial 18-month trial period. Some patients who received treatment in the early stages maintained stable memory and thinking abilities for up to four years, with some even showing improvement. This represents the first time such long-lasting benefits have been documented, giving patients precious additional time with their loved ones.

The Bigger Picture

Kisunla® is part of a new wave of disease-modifying therapies for Alzheimer's, joining lecanemab (Leqembi®) as the second anti-amyloid immunotherapy to receive full FDA approval. These treatments signal a paradigm shift in how we approach Alzheimer's disease—moving from symptomatic management to addressing the underlying pathology of the disease itself.

While Kisunla® doesn't cure Alzheimer's, it offers something that has eluded researchers for generations: the ability to meaningfully slow disease progression and preserve cognitive function. As research continues and more therapies enter the pipeline, there is renewed hope that we are turning a corner in what's possible for Alzheimer's treatment. Sources : U.S. Food and Drug Administration. "FDA approves treatment for adults with Alzheimer's disease." July 2, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease Alzheimer's Research UK. "AAIC 2025: The future of Alzheimer's research is here." August 6, 2025. https://www.alzheimersresearchuk.org/blog/aaic-2025-the-future-of-alzheimers-research-is-here/