Eli Lilly and Company  announced that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab), a treatment for mild cognitive impairment and mild dementia due to Alzheimer’s disease in Apolipoprotein E ε4 (ApoE ε4) heterozygote or non-carrier adult patients. Kisunla is administered via intravenous infusion every four weeks and is the first approved amyloid-targeting therapy for Alzheimer’s disease in Australia. It is also the only therapy of its kind backed by data supporting cessation of treatment once amyloid plaques are removed.

This marks the 13th regulatory authorization globally for Kisunla, which has demonstrated the ability to significantly slow cognitive and functional decline in patients with early symptomatic Alzheimer’s disease.

"In our Phase 3 TRAILBLAZER-ALZ 2 study, Kisunla showed it could help patients retain their independence longer—performing daily tasks and remembering essential information," said Ilya Yuffa, Executive Vice President and President of Lilly International. "Early diagnosis and timely treatment are key to maximizing the benefits."

The TGA approval is supported by data from the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 trials. Key findings include:

• A 35% reduction in cognitive and functional decline at 18 months versus placebo

• A 39% reduction in the risk of disease progression to the next clinical stage

• A new modified titration schedule shown to reduce the incidence of amyloid-related imaging abnormalities (ARIA) while preserving efficacy

Alzheimer’s disease affects an estimated 600,000 Australians, with nearly 450,000 in the early stages who may be eligible for Kisunla. The disease remains the third leading cause of death in the country.

Kisunla is now approved in Australia, the United States, Japan, China, the United Kingdom, and several countries across Asia, the Middle East, and Latin America.