FDA changes imaging recommendations for patients taking popular Alzheimer's drug
The U.S. Food and Drug Administration is updating its recommendations related to the use of MRI scans to guide medication management for a popular Alzheimer’s drug.
Leqembi (lecanemab) was approved by the FDA in 2023. It is an infusion drug that has been shown to reduce Alzheimer’s-related cognitive decline by up to 27%.
Though effective, the drug comes with caveats; it has been shown to cause amyloid-related imaging abnormalities (ARIA). Symptoms of ARIA include headache, confusion, dizziness, vision changes and nausea. In clinical trials, ARIA symptoms occurred in 2.8% of participants who received the drug. Despite the low incidence, ARIA remains a concern among many providers who would be prescribing the drug.
ARIA is typically monitored via MRI. Previously, the prescribing information recommended MRI imaging before the 5th, 7th and 14th infusions. However, new safety data suggest patients would benefit from an additional scan prior to their 3rd infusion, the FDA announced Thursday.
“ARIA-E can progress after initial detection on MRI. Identifying patients with ARIA-E can lead healthcare professionals, patients, and their families to delay or discontinue Leqembi treatment to potentially mitigate these serious and, in some cases, fatal events,” a news release from the agency reads.
The new recommendations were released following routine safety assessments. Those revealed that six deaths owed to ARIA occurred during early treatment. In total, 24 cases of serious ARIA-E occurred prior to patients’ 4th infusions. These patients showed ARIA-E symptoms, which prompted an earlier unscheduled MRI for clinical assessment.
These findings motivated the FDA to be more proactive in updating their imaging recommendations.
“We are requiring the prescribing information of Leqembi (lecanemab) to include an earlier monitoring MRI between the 2nd and 3rd infusion. This revised language will be in the monitoring schedule (Section 2.3) of the prescribing information. In the meantime, we want to bring public attention to this issue,” the agency advises.
To learn more about the FDA’s findings and new recommendations, click here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.