FDA to Recommend Additional, Earlier Monitoring for Patients with Alzheimer’s Disease Taking Leqembi (lecanemab)

https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommend-additional-earlier-mri-monitoring-patients-alzheimers-disease-taking-leqembi-lecanemab?utm_medium=email&utm_source=govdelivery FDA to Recommend Additional, Earlier Monitoring for Patients with Alzheimer’s Disease Taking Leqembi (lecanemab) The U.S. Food and Drug Administration (FDA) is recommending an additional, earlier magnetic resonance imaging (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 there have been deaths. The Alzheimer’s disease community has been aware of ARIA-E associated with Leqembi, and current prescribing information recommends MRI imaging before the 5th, 7th, and 14th infusions. However, after an in-depth analysis of this safety issue, the Agency has determined that an additional monitoring MRI 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 health care professionals, patients, and their families to delay or discontinue Leqembi treatment to potentially mitigate these serious and, in some cases, fatal events.