The approval applies to individuals with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers.
Kisunla, administered as a monthly infusion, is already available in several countries, including the US, Japan, and China.
The EC decision follows evidence from clinical trials showing significant slowing of cognitive and functional decline in patients.
According to Lilly, it is the first therapy targeting amyloid plaques with evidence supporting treatment completion once these plaques are reduced to minimal levels.
Also, the drug could potentially lower treatment costs and the frequency of infusions.
Lilly International executive vice president and president Patrik Jonsson said: “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.
“The data shows that the earlier patients are identified, diagnosed, and treated with Kisunla, the greater the response to treatment.
“This authorisation brings a new option to patients in Europe, offering hope and the potential for more time to focus on what matters most.”
Amyloid plaques, resulting from the accumulation of amyloid protein, are linked to memory and cognitive issues in Alzheimer’s patients.
Kisunla is said to help reduce these plaques, thereby slowing the progression of the disease.
The therapy’s ability to mitigate cognitive decline may help maintain patients’ independence for longer periods, said Lilly.
The EC approval is based on findings from the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 clinical trials.
The Phase III TRAILBLAZER-ALZ 2 trial showed that Kisunla significantly slowed cognitive and functional deterioration.
Its dosing schedule was informed by the Phase IIIb TRAILBLAZER-ALZ 6 study.
The study indicated that a gradual titration approach reduced the incidence of amyloid-related imaging abnormalities (ARIA) while achieving similar outcomes in amyloid plaque and P-tau217 reduction.
Recently, Lilly received the US Food and Drug Administration (FDA) breakthrough therapy designation for olomorasib, an investigational KRAS G12C inhibitor.