Eli Lilly and Company has secured marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) for donanemab, a revolutionary treatment for mild cognitive impairment and mild dementia due to Alzheimer's disease. Marketed as Kisunla, this injectable monoclonal antibody targets amyloid plaques in the brain, slowing cognitive and functional decline.
A New Class of Treatment:
Donanemab is part of a new class of amyloid-targeting therapies, offering hope to eligible adults who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. This treatment has demonstrated meaningful results in clinical trials, significantly slowing disease progression. Notably, donanemab is the only therapy with evidence supporting stopping treatment when amyloid plaques are removed.
Chris Stokes, President and General Manager of UK and Northern Europe at Lilly, expressed delight at the MHRA approval, highlighting Lilly's 35-year commitment to Alzheimer's disease research. Stokes emphasized the importance of early diagnosis and equitable access to innovative treatments like donanemab.
I believe we can improve the standard of care for people living with Alzheimer’s disease. The authorization of donanemab for eligible adults is welcome news. The UK now needs to rapidly increase NHS capacity and expertise in diagnostics and treatment facilities to enhance the management of Alzheimer’s disease for the benefit of people today and tomorrow.Cath Mummery, Professor, Consultant Neurologist at University College London Hospitals NHS Foundation Trust and Chair of the NIHR Dementia Translational Research Collaboration.
Addressing the Alzheimer's Burden: In the United Kingdom, approximately 982,000 people live with dementia, with 50-75% of cases attributed to Alzheimer's disease. This condition is the leading cause of death and imposes an economic cost of £42 billion annually. Unpaid care is the largest component, with costs per person increasing threefold from mild to severe dementia.
Amyloid is a naturally produced protein that can clump together, forming plaques in the brain. This treatment aims to preserve patients' ability to remember information, manage finances, and maintain independence. Results showed donanemab significantly slowed cognitive and functional decline, meeting the primary trial endpoint.
While the MHRA has approved donanemab, the National Institute for Health and Care Excellence (NICE) has published draft guidance not recommending reimbursement for use in the NHS. Eli Lilly remains confident in the treatment's clinical and cost-effectiveness and will work closely with NICE during the consultation period.
(Input From Various Sources)
(Rehash/Neha Kamble/MSM)