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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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Being Patient broke the news in on Wednesday, May 21, 2025.
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