Eli Lilly's Kisunla Receives Marketing Authorization in Australia for Early Symptomatic Alzheimer's Treatment
Reuters
May 22, 2025
Eli Lilly's Kisunla Receives Marketing Authorization in Australia for Early Symptomatic Alzheimer's Treatment
Eli Lilly and Company has announced that the Australian Therapeutic Goods Administration $(TGA)$ has granted marketing authorization for Kisunla (donanemab), an injection for intravenous infusion, for the treatment of early symptomatic Alzheimer's disease. This marks the 13th regulatory approval for Kisunla globally. The authorization is specifically for adult patients who are Apolipoprotein E-ε4 heterozygotes or non-carriers. Kisunla is the first amyloid-targeting therapy for Alzheimer's registered in Australia and is unique in its approach of targeting amyloid plaques with evidence supporting the cessation of therapy once plaques are removed. The authorization is based on positive results from the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 clinical trials, which showed significant slowing of cognitive and functional decline in patients. This development offers new hope to the estimated 450,000 Australians in the early stages of Alzheimer's disease.
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