Eli Lilly and Company’s corporate headquarters in Indianapolis. (Credit: Momoneymoproblemz/Wikimedia Commons. (Creative Commons))
Eli Lilly and Company (Lilly) has received the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) authorisation for marketing its Kisunla (donanemab) in Great Britain.
Kisunla is indicated for adults with mild cognitive impairment and mild dementia due to Alzheimer’s disease (AD), who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.
The drug, administered as an intravenous injection every four weeks, can cause serious side effects, including amyloid-related imaging abnormalities (ARIA), and infusion-related reactions.
Amyloid is a protein produced naturally in the body, whose excessive buildup may cause amyloid plaques in the brain and may lead to AD.
Kisunla works by helping the body remove the excessive buildup of amyloid plaques and slow the cognitive and functional decline that may affect a patient’s ability to do daily tasks.
Lilly said that Kisunla is the only amyloid plaque-targeting therapy with evidence to support halting the treatment when amyloid plaques are removed.
Eli Lilly and Company executive vice president and Lilly International president Ilya Yuffa said: “People around the world want and deserve access to treatment options for this disease.
“This approval in Great Britain is another significant step to ensure patients with Alzheimer’s disease can receive treatment with this new class of amyloid-targeting therapies.
“Donanemab demonstrated meaningful results for people with early symptomatic Alzheimer’s disease by significantly slowing cognitive and functional decline in our TRAILBLAZER-ALZ 2 study.”
TRAILBLAZER-ALZ 2 is a placebo-controlled Phase 3 study that evaluated the safety and efficacy of Kisunla in people with early symptomatic AD, with confirmed AD neuropathology.
The Phase 3 study enrolled 1,736 participants across eight countries, selected based on cognitive assessments alongside evidence of AD pathology.
Great Britain is the third major market to approve Kisunla, following the US in July this year, and Japan in September.
Lilly said it will continue to study the drug in multiple clinical trials, including TRAILBLAZER-ALZ 3, TRAILBLAZER-ALZ 5, and TRAILBLAZER-ALZ 6.
TRAILBLAZER-ALZ 3 will focus on reducing the risk of progression to symptomatic AD, and TRAILBLAZER-ALZ 5 on early symptomatic AD, currently enrolling in China and Korea.
TRAILBLAZER-ALZ 6 is focused on expanding the understanding of ARIA through novel MRI sequences, blood-based biomarkers, and different dosing regimens of Kisunla.
