Eli Lilly and Company has announced that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorisation for Kisunla (donanemab), an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in adults who are Apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.

Kisunla is the first amyloid-targeting therapy for people with Alzheimer's registered in Australia and the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed.

"It is exciting to see Kisunla's marketing authorisation in Australia, marking it as the 13th regulatory authorisation. In our TRAILBLAZER-ALZ 2 Phase 3 study, results showed that Kisunla significantly slowed the cognitive and functional decline in patients with early symptomatic Alzheimer's disease, which allowed them more time to do things that mattered most to them like remembering information, making meals, managing finances, and maintain independence," said Executive Vice President and President of Lilly International, and Company, Ilya Yuffa.

It's estimated that 600,000 Australians are currently living with Alzheimer's disease, with approximately 450,000 of these individuals in the early stages of the disease who could be assessed to determine eligibility for treatment with Kisunla. Alzheimer's disease is the third leading cause of death in Australia.

The registration of Kisunla in Australia was based on the TRAILBLAZER-ALZ 2 Phase 3 and TRAILBLAZER-ALZ 6 clinical trial data. The TRAILBLAZER-ALZ 2 study demonstrated that Kisunla significantly slowed cognitive and functional decline characterised by more significant memory and thinking deficits, with related impacts on daily functioning and requiring higher levels of caregiver support by up to 35 percent compared to placebo at 18 months and reduced the risk of progressing to the next clinical stage of disease by 39 percent over the same period.

Amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and with hemorrhage/ hemosiderosis (ARIA-H) are side effects within the class of therapies that are usually asymptomatic, although serious and life-threatening events can rarely occur. ARIA-E can cause focal neurologic deficits that can mimic ischemic stroke, the product information in Australia includes a boxed warning that notes treatment to dissolve blood clots should be carefully considered by the patient's doctor.    

The titration schedule approved in Australia is based on TRAILBLAZER-ALZ 6, which demonstrated that the incidence of ARIA-E at 24 weeks was significantly lowered versus the original dosing schedule while preserving Kisunla's ability to reduce amyloid plaque and plasma P-tau217. The modified titration schedule has been submitted for regulatory review in other countries.

Donanemab is now approved in the United States, Japan, China, the United Kingdom, the UAE, Qatar, Kuwait, Bahrain, Singapore, Taiwan, Brazil, Mexico and Australia.