FDA

Leqembi label to add earlier MRI monitoring

September 1, 2025

FDA is recommending additional, earlier MRI monitoring prior to the 3^rd infusion for patients with Alzheimer’s disease taking Leqembi (lecanemab). The earlier monitoring can identify individuals with amyloid-related imaging abnormalities with edema (ARIA-E), which is characterized by brain swelling or fluid buildup. ARIA-E is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur and can be fatal.

Current prescribing information recommends MRI imaging before the 5^th, 7^th, and 14^th infusions. However, after an in-depth analysis of this safety issue after 6 deaths early in the treatment course of Leqembi were identified during routine pharmacovigilance, the agency has determined that additional MRI monitoring prior to the 3^rd infusion can potentially help identify ARIA-E events earlier.

ARIA-E can progress after initial detection on MRI. Identifying patients with ARIA-E can lead HCPs, patients, and their families to delay or discontinue Leqembi treatment to potentially mitigate these serious and, in some cases, fatal events.

Source:

FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer’s disease taking Leqembi (lecanemab). [News release]. 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommend-additional-earlier-mri-monitoring-patients-alzheimers-disease-taking-leqembi-lecanemab