Monoclonal antibodies for early Alzheimer disease: a long road to discovery and marketing approval, a short timeline for health systems to organise services

Disease-modifying drugs are now available for the treatment of early Alzheimer disease (AD). These agents belong to the class of monoclonal antibodies (mAbs) and target amyloid-β1–42 in different molecular epitopes and aggregation states. In the United States, two anti-amyloid drugs are available on the market following approval by the Food and Drug Administration (FDA): lecanemab, approved in 2023, and donanemab, approved in 2024. Earlier, in 2022, another mAb, aducanumab, was available in the US before being withdrawn in 2024. Since then, other countries have aligned with the FDA’s decision and licensed these antiamyloid mAbs for clinical use in patients with mild cognitive impairment and mild dementia due to AD.