Lilly's Kisunla™ (donanemab) Approved in Great Britain for Mild Cognitive Impairment and Mild Dementia in Specific Alzheimer's Patients
Thursday, October 24, 2024
Eli Lilly and Company has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for donanemab, a treatment targeting mild cognitive impairment and mild dementia caused by Alzheimer's disease.
Donanemab works by reducing the excessive buildup of amyloid plaques, which are linked to memory and cognitive problems in Alzheimer's disease.
By slowing down the cognitive and functional decline associated with the condition, donanemab may help patients maintain essential daily activities, such as managing finances or preparing meals.
This new therapy, administered via intravenous infusion every four weeks, is approved for use in Great Britain in adults who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.
Although this treatment represents a significant advancement in Alzheimer's care, it is not without risks. Donanemab has been associated with serious side effects, including amyloid-related imaging abnormalities (ARIA) and infusion-related reactions. Administered as a fixed dose, the treatment is delivered through an intravenous infusion every four weeks.
This restriction is in line with requirements for amyloid-targeting treatments in the region. Notably, donanemab stands out as the only therapy in its class with evidence to suggest that treatment may be discontinued once amyloid plaques have been successfully cleared.
Great Britain becomes the third major market to authorise the use of donanemab, marketed as Kisunla. Alzheimer's disease remains the leading cause of death in the UK, contributing to a significant portion of the 982,000 estimated dementia cases across the country.
This disease not only affects individuals but also poses a substantial economic burden, with the cost to families, patients, and the public sector expected to reach £42 billion in 2024.
The approval of donanemab in Great Britain is based on the findings of the TRAILBLAZER-ALZ 2 study, a Phase 3 trial that demonstrated the therapy’s efficacy in slowing cognitive and functional decline in patients with early symptomatic Alzheimer's.
Ongoing research continues, with several clinical trials such as TRAILBLAZER-ALZ 3, 5, and 6 focusing on different stages of Alzheimer's and improving the understanding of the treatment’s effects.
In light of this approval, there is a recognised need for the National Health Service (NHS) to bolster diagnostic and treatment capacities to manage Alzheimer's effectively.
Source: lilly.com
