By Fineline Cube 
The Australian Therapeutic Goods Administration (TGA) this week approved Eli Lilly and Company’s (NYSE: LLY) 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. This marks a significant advancement in the treatment landscape for Alzheimer’s disease in Australia.
Kisunla’s Unique Position
Kisunla is the first amyloid-targeting therapy registered in Australia for people with Alzheimer’s and the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. The TGA approval is based on results from the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 studies.
Clinical Trial Results
The TRAILBLAZER-ALZ 2 study demonstrated that Kisunla significantly slowed cognitive and functional decline 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. The TRAILBLAZER-ALZ 6 study showed that the incidence of amyloid-related imaging abnormalities (ARIA) with edema/effusion (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.-Fineline Info & Tech