Eli Lilly (LLY) announced that the Medicines and Healthcare products Regulatory Agency, or 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, or 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.
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