FDA
Leqembi label to add earlier MRI monitoring
FDA is recommending additional, earlier MRI monitoring prior to the 3rd 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 5th, 7th, and 14th 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 3rd 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