The U.S. Food and Drug Administration (FDA) is recommending an additional, earlier magnetic resonance imaging (MRI) monitoring prior to the 3 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 5, 7, and 14 infusions. However, after an in-depth analysis of this safety issue, the Agency has determined that an additional monitoring MRI prior to the 3 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.