Eli Lilly and Company (LLY) Gains Approval in Australia for Early Alzheimer's Treatment

Eli Lilly and Company (NYSE:LLY) recently announced that Australia's Therapeutic Goods Administration (TGA) has approved Kisunla (donanemab) for marketing. The drug, administered via intravenous infusion every four weeks, is intended to treat adults with mild cognitive impairment or mild dementia caused by Alzheimer's disease, specifically those who are either non-carriers or have a single ApoE ε4 gene.

Kisunla stands out as the first amyloid-targeting Alzheimer’s therapy approved in Australia. It’s also the only treatment of its kind supported by clinical evidence, allowing patients to stop treatment once amyloid plaques are cleared.

However, medical experts have noted that fewer than 20% of dementia patients are likely to qualify for the therapy, which may cost patients over $80,000 out of pocket.

Professor Christopher Rowe, head of the Australian Dementia Network, emphasized the significance of the approval, noting that it’s the first Alzheimer's treatment in 25 years to impact disease progression. While older medications only temporarily eased symptoms, Kisunla has shown it can slow cognitive decline by roughly 33%.

That said, the drug comes with risks. It has been linked to brain swelling and bleeding, particularly in individuals carrying two ApoE ε4 genes.

According to Eli Lilly and Company (NYSE:LLY)'s release, around 600,000 Australians are currently living with Alzheimer’s, with about 450,000 in the early stages who might be evaluated for Kisunla treatment. Alzheimer’s remains the third leading cause of death in the country.

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