FDA labeling for lecanemab (Leqembi) and donanemab (Kisunla) requires APOE genotyping prior to initiation due to APOE4-dose-dependent ARIA-E risk; regulatory framework anchored in earlier MAb-class evidence including bapineuzumab.

Evidence span

FDA labeling for lecanemab (Leqembi) and donanemab (Kisunla) requires APOE genotyping prior to initiation due to APOE4-dose-dependent ARIA-E risk; regulatory framework anchored in earlier MAb-class evidence including bapineuzumab.

Method & conditions

Evidence type

observational

Method

manual state transition

Species

Homo sapiens

Conditions

FDA prescribing information, lecanemab approval Jan 2023, donanemab approval July 2024.

Replicated

not yet

Confidence basis

operator-supplied frontier prior; review required