Medicine company Eli Lilly and Company (NYSE: LLY) announced on Wednesday that it has received marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) for Kisunla (donanemab-azbt) in Great Britain.

This intravenous therapy targets mild cognitive impairment and mild dementia due to Alzheimer's disease specifically for apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. Great Britain marks the third significant market to approve donanemab, following its initial approval in the United States in July 2024 and in Japan in September 2024.

Approximately 982,000 individuals in the UK live with dementia, with 50-75% of cases linked to Alzheimer's disease, representing a significant societal cost estimated at £42 billion in 2024. Unpaid care constitutes the largest portion of this cost, escalating as dementia severity increases. Donanemab aims to alleviate memory and cognitive decline by targeting and facilitating the removal of amyloid plaques, which are implicated in Alzheimer's disease progression.

The drug, administered every four weeks, has potential serious side effects, including amyloid-related imaging abnormalities (ARIA). Donanemab's clinical efficacy was demonstrated in the Phase 3 TRAILBLAZER-ALZ 2 study, which involved 1,736 participants across eight countries and focused on patients with early symptomatic Alzheimer's disease. Ongoing trials, such as TRAILBLAZER-ALZ 3 and TRAILBLAZER-ALZ 5, continue to explore the drug's safety and effectiveness in various Alzheimer's disease contexts.

Eli Lilly remains committed to advancing treatment options for Alzheimer's disease and other critical health challenges, reflecting a legacy of nearly 150 years in medicine innovation.