On 29 October 2024, Eli Lilly announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study, which demonstrated that patients with early symptomatic Alzheimer’s disease (AD) who received a slightly modified titration of Kisunla™ (donanemab) showed a reduction in amyloid-related imaging abnormalities with oedema/effusion (ARIA-E) at the 24-week primary endpoint. Eli Lilly reports that the modified titration of Kisunla™ lowered ARIA-E to 14% compared to 24% in patients receiving the standard dosing regimen. Eli Lilly is intending to submit this data to global regulators for a potential label update for Kisunla™.
One week earlier, Eli Lilly announced that Kisunla™ was approved in the UK as a treatment for mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients who are apolipoprotein E ε4 heterozygotes or non-carriers. Kisunla™ was first approved in the US (July 2024) and subsequently in Japan (September 2024) for the same indication.