Eli Lilly and Company (NYSE: LLY) announced today 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 ?4 (ApoE ?4) 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.
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.
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 ?4 (ApoE ?4) 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.
