Eli Lilly and Company has received marketing authorisation from the Australian Therapeutic Goods Administration (TGA) for Kisunla (donanemab) to treat mild cognitive impairment and mild dementia due to Alzheimer’s disease in the adult population.
This authorisation allows for the intravenous infusion of Kisunla every four weeks to treat the condition. The drug is specifically indicated for those who are Apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.
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Kisunla is be the first amyloid-targeting therapy for Alzheimer’s registered in the country.
Kinsunla can reduce amyloid plaques, created by the clumping of naturally occurring amyloid proteins, potentially slowing the functional and cognitive decline in those with early symptomatic Alzheimers’s.
The decision to register the therapy was supported by data from the Phase III TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 trials.
The TRAILBLAZER-ALZ 2 trial showcased the therapy’s efficacy, slowing cognitive and functional decline against a placebo at 18 months and minimising disease progression risk by 39% over the same time.
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By GlobalDataThe approved titration schedule in the country, based on the TRAILBLAZER-ALZ 6 trial, significantly minimises the incidence of amyloid-related imaging abnormalities (ARIA) with oedema/effusion at 24 weeks against the original dosing schedule while maintaining Kisunla’s plaque-reducing and plasma P-tau217-lowering abilities.
Eli Lilly has also submitted this modified schedule for regulatory review in other countries.
Kisunla has been approved in Australia, Bahrain, Brazil, China, Japan, Kuwait, Mexico, Qatar, Singapore, Taiwan, the UK, the United Arab Emirates and the US.
Eli Lilly and Company executive vice-president and Lilly International president Ilya Yuffa stated: “It is exciting to see Kisunla’s marketing authorisation in Australia, marking it as the 13th regulatory authorisation.
“In our TRAILBLAZER-ALZ 2 Phase III study, results showed that Kisunla significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s, which allowed them more time to do things that mattered most to them, like remember information, make meals, manage finances and maintain independence.”
Eli Lilly had previously announced an expansion of its partnership with Purdue University, with a planned investment of up to $250m over the next eight years to accelerate innovation across the pharma pipeline.
