FDA advises enhanced oversight for Alzheimer's patients using Leqembi

Written by Emily J. Thompson, Senior Investment Analyst

Source: SeekingAlpha

Updated: Aug 29 2025

0mins

Source: SeekingAlpha

FDA Recommendations for Alzheimer's Drug Monitoring

Earlier Brain Imaging Scans: The FDA has advised that brain imaging scans should be conducted earlier to monitor for brain swelling before the third infusion of the Alzheimer's drug Leqembi, developed by Eisai and Biogen. This is aimed at detecting amyloid-related imaging abnormalities with edema (ARIA-E), which can indicate brain swelling or fluid accumulation.
Response to Serious Outcomes: This recommendation comes in light of six reported deaths occurring early in the treatment, which prompted a thorough review of serious and fatal outcomes associated with ARIA-E prior to the fifth infusion of Leqembi.
Updated MRI Scan Guidelines: Previously, the prescribing information for Leqembi required MRI scans before the fifth, seventh, and fourteenth infusions. The FDA now mandates an update to include an MRI scan between the second and third infusions to enhance patient safety.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.