The European Commission (EC) has granted marketing authorisation for Eli Lilly’s Kisunla (donanemab), a treatment for early symptomatic Alzheimer’s disease (AD).
AD affects nearly 7 million people in Europe and is characterised by progressive cognitive decline, including memory loss and impaired thinking. A driver of the condition is the excessive build-up of amyloid plaque in the brain.
Kisunla, administered via infusion, works by targeting and clearing this build-up, with the aim of preserving cognitive function and slowing disease progression.
The EC marketing authorisation was supported by data from the phase 3 TRAILBLAZER-ALZ 2 trial, which showed Kisunla significantly slowed cognitive and functional decline compared with placebo.
A subsequent phase 3b study, TRAILBLAZER-ALZ 6, evaluated alternative dosing regimens in relation to amyloid-related imaging abnormalities (ARIA) – a class-related side effect that can manifest as ARIA with oedema/effusion (ARIA-E) or haemorrhage/haemosiderosis (ARIA-H). The study reported positive results with a lower dosing schedule, consistent with the efficacy observed in TRAILBLAZER-ALZ 2.
Following the EC marketing authorisation, Kisunla can now be prescribed across the EU for adults with mild cognitive impairment or mild dementia stages of AD, with confirmed amyloid pathology, who are apolipoprotein E (ApoE4) heterozygotes or non-carriers.
“Kisunla demonstrated meaningful results in people with early symptomatic Alzheimer’s disease by significantly slowing cognitive and functional decline in our phase 3 TRAILBLAZER-ALZ 2 study,” said Patrik Jonsson, executive vice president and president of Lilly International. “This authorisation brings a new option to patients in Europe – offering hope and the potential for more time to focus on what matters most.”