Lilly's Kisunla (Donanemab) Receives Marketing Authorization in Australia for the Treatment of Early Symptomatic Alzheimer's Disease
- On May 21, 2025, Eli Lilly announced that Kisunla received approval from Australia's Therapeutic Goods Administration to be marketed for the treatment of early symptomatic Alzheimer's disease in adults.
- This approval was based on results from the TRAILBLAZER-ALZ 2 Phase 3 trial, which demonstrated that Kisunla effectively reduced the progression of memory loss and impairments in daily functioning, and included a boxed warning regarding amyloid-related imaging abnormalities .
- Kisunla is the pioneering amyloid plaque–targeting treatment approved in Australia, given as an intravenous infusion every four weeks, for adults who are Apolipoprotein E-4 heterozygotes or non-carriers.
- The TRAILBLAZER-ALZ 2 study found Kisunla slowed decline by up to 35% and reduced progression risk by 39% over 18 months, allowing patients more time to maintain memory and daily activities, according to Ilya Yuffa from Eli Lilly.
- The approval expands Kisunla's regulatory authorizations to 13 countries, suggesting broader treatment options for an estimated 450,000 Australians in early Alzheimer's stages, though risks and study uncertainties remain.
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Prescription drug to slow Alzheimer’s disease approved in Australia
A groundbreaking treatment to slow the progression of Alzheimer's Disease has been cleared for prescription in Australia. The Therapeutic Goods Administration has approved the medication for some people with early disease symptoms. It's the first new treatment of its kind in 25 years.
·Sydney, Australia
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