• 24 Oct 2024
• Admin
• News Article

MHRA Grants Marketing Approval to Lilly's Kisunla to Treat Mild Cognitive Impairment and Mild Dementia

UK MHRA grants marketing approval to Lilly's Kisunla to treat mild cognitive impairment and mild dementia due to Alzheimer's disease

Overview

Eli Lilly and Company, a medicine company turning science into healing to make life better for people around the world, announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in eligible adults in Great Britain. Eligible patients are limited to apolipoprotein E e4 (ApoE e4) heterozygotes or non-carriers, which is a requirement for the class of currently approved amyloid-targeting therapies in Great Britain. Donanemab is the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. Great Britain is the third major market to approve donanemab, marketed as Kisunla.

Statement from Eli Lilly and Company

• "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, which could give them more time in the early symptomatic stage of the disease to do what matters most to them," said Ilya Yuffa, executive vice president and president of Lilly International, Eli Lilly and Company. 
• "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."

Dementia Cases in UK

• Currently, there are 982,000 people estimated to be living with dementia in the United Kingdom (UK), with 50-75% of cases attributable to Alzheimer's disease. 
• It is the leading cause of death in the UK and an economic cost to society. 
• The total cost of dementia on patients, families and the public sector is estimated to be £42 billion in 2024. 
• Unpaid care is the largest component, with costs per person increasing threefold from mild to severe dementia.
• About Amyloid
• Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. 
• The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer's disease.  
• Donanemab can help the body remove the excessive buildup of amyloid plaques and slow the cognitive and functional decline that may diminish people's ability to remember information, make meals, manage finances, and maintain independence.  

Statement from an Expert

• "I believe we can improve the standard of care for people living with Alzheimer's disease. Despite years of medical research, until recently, there has been little progress in treatment options for this disease. The authorisation of donanemab for eligible adults is welcome news.” 
• “Great Britain now needs to rapidly increase National Health Service (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," said Professor Cath Mummery, Consultant Neurologist at University College London Hospitals NHS Foundation Trust and Chair of the NIHR Dementia Translational Research Collaboration.

About Donanemab

• Donanemab is an amyloid-targeting treatment for people with mild cognitive impairment and mild dementia due to Alzheimer's disease in adult patients who are apolipoprotein E e4 (ApoE e4) heterozygotes or non-carriers. 
• Donanemab can cause serious side effects, including amyloid-related imaging abnormalities (ARIA), and infusion-related reactions. 
• Donanemab is a fixed dose prescription medicine administered intravenously every four weeks.

About TRAILBLAZER-ALZ 2

• TRAILBLAZER-ALZ 2 (NCT04437511) is a phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia due to Alzheimer's disease) with the presence of confirmed Alzheimer's disease neuropathology. 
• The trial enrolled 1,736 participants, across 8 countries, selected based on cognitive assessments in conjunction with evidence of Alzheimer's disease pathology. 
• The phase 3 TRAILBLAZER-ALZ 2 study results were published in the Journal of the American Medical Association (JAMA).

Lilly’s Research on Donanemab 

Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, which is focused on reducing risk of progression to symptomatic Alzheimer's disease in participants with preclinical AD; TRAILBLAZER-ALZ 5, a registration trial for early symptomatic AD currently enrolling in China and Korea; and TRAILBLAZER-ALZ 6, which is focused on expanding our understanding of ARIA through novel MRI sequences, blood-based biomarkers, and different dosing regimens of donanemab.