Eli Lilly’s Alzheimer’s drug cleared in Australia despite setback for Biogen

Eli Lilly (NYSE:LLY) has received regulatory approval to market its Alzheimer’s therapy Kisunla (donanemab) in Australia, making it the country’s first amyloid-targeting treatment available for the memory-robbing disease following a setback for a rival Alzheimer’s drug from Biogen (NASDAQ:BIIB).

The Australian Therapeutic Goods Administration (TGA) issued the marketing authorization for Kisunla to treat certain adults with mild cognitive impairment and mild dementia linked to Alzheimer’s, the company said late Wednesday.

The approval was backed by data from the company’s late-stage trials TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6, which tested donanemab in more than 2,500 patients with early symptomatic Alzheimer’s disease.

The decision hands a first-mover advantage to LLY in the Australian market for amyloid-targeting Alzheimer’s therapies after the TGA in March declined to approve rival Alzheimer’s drug Leqembi (lecanemab) developed by Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESAIY).

Shares of Swedish biopharma BioArctic (OTCPK:BRCTF), which invented lecanemab and has partnered with Eisai (OTCPK:ESALF) to market the infusion in the Nordic region, fell ~11% in European trading after donanemab’s approval in Australia.