Eli Lilly Kisunla secures Australian nod for early symptomatic Alzheimer's disease
Indianapolis: Eli Lilly and Company has received marketing authorization from the Australian Therapeutic Goods Administration (TGA) 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 an amyloid-targeting therapy for people with Alzheimer's registered in >Australia and an amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed.
Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. Kisunla can help remove the excessive buildup of amyloid plaques and help slow the cognitive and functional decline in patients with early symptomatic Alzheimer's disease.
"It is exciting to see Kisunla's marketing authorization in Australia, marking it as the 13th regulatory authorization. In our TRAILBLAZER-ALZ 2 Phase 3 study, results showed that Kisunla significantly slowed 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 remember information, make meals, manage finances, and maintain independence," said Ilya Yuffa, executive vice president and president of Lilly International, Eli Lilly and Company. "As our data showed, the earlier patients are identified, diagnosed, and treated with Kisunla, the greater their response to treatment."
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 inAustralia 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 — characterized by more significant memory and thinking deficits, with related impacts on daily functioning and requiring higher levels of caregiver support—by up to 35% compared to placebo at 18 months and reduced the risk of progressing to the next clinical stage of disease by 39% 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. Because 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, United Kingdom, UAE, Qatar, Kuwait, Bahrain, Singapore, Taiwan, Brazil,Mexico and Australia.
Donanemab is a prescription medicine administered intravenously every four weeks.
