Eli Lilly’s Kisunla receives marketing authorization in Australia for mild Alzheimer’s

AUSTRALIA—Eli Lilly and Company has secured marketing authorization from the Australian Therapeutic Goods Administration (TGA) for Kisunla (donanemab).

 This drug is an intravenous infusion administered every four weeks, designed to treat mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients who are Apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.

Kisunla is the first amyloid-targeting therapy registered in Australia for treating Alzheimer’s and stands out as the only one with evidence suggesting that treatment can be discontinued once amyloid plaques are cleared.

The authorization of Kisunla in Australia marks its 13th regulatory approval worldwide.

Kisunla is now approved in major markets, including the United States, Japan, China, the UK, and others.

Alzheimer’s disease is characterized by the accumulation of amyloid plaques in the brain, which can lead to cognitive and functional decline.

Amyloid is a naturally occurring protein that, when clumped together, forms these plaques.

Kisunla aims to reduce these amyloid plaques, potentially slowing the progression of the disease in individuals with early symptomatic Alzheimer’s.

Ilya Yuffa, Executive Vice President and President of Lilly International, noted that the Phase III TRAILBLAZER-ALZ 2 study demonstrated that Kisunla significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s.

This allows patients more time to engage in meaningful activities, such as remembering information, preparing meals, managing finances, and maintaining independence.

Yuffa also emphasized that earlier diagnosis and treatment with Kisunla lead to more favorable outcomes.

The decision by the TGA to register Kisunla was supported by data from the Phase III TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 trials.

The TRAILBLAZER-ALZ 2 trial demonstrated that Kisunla slowed cognitive and functional decline compared to a placebo over 18 months and reduced the risk of disease progression by 39% during the same period.

The approved titration schedule in Australia, based on the TRAILBLAZER-ALZ 6 trial, significantly minimizes the incidence of amyloid-related imaging abnormalities (ARIA) with edema/effusion at 24 weeks compared to the original dosing schedule.

This reduction in ARIA incidence is achieved while maintaining Kisunla’s ability to reduce plaque and lower plasma P-tau217 levels.

Eli Lilly has submitted this modified schedule for regulatory review in other countries as well.

In Australia, where Alzheimer’s is the third leading cause of death, approximately 600,000 people are living with the disease.

Of these, around 450,000 are in the early stages and could be eligible for Kisunla treatment.

This approval represents a significant advancement in the treatment landscape for Alzheimer’s disease, offering a potential disease-modifying therapy for those in the early stages of the condition.

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