Aug 28 (Reuters) - The U.S. Food and Drug Administration said on Thursday it is recommending additional, earlier scans to monitor brain swelling prior to the third infusion for patients with Alzheimer's disease taking Eisai and Biogen's drug Leqembi.
The earlier monitoring can identify individuals with amyloid-related imaging abnormalities with edema (ARIA-E), which is characterized by brain swelling or fluid buildup.
The FDA said it identified six deaths early in treatment, which prompted an in-depth analysis of serious and fatal outcomes related to ARIA-E before the fifth Leqembi infusion.
The health regulator said it is requiring the prescribing information of Leqembi to include an earlier monitoring between the second and third infusion.
The companies did not immediately respond to a Reuters request for comment.
The current prescribing information of Leqembi recommends MRI imaging before the fifth, seventh and 14th infusions.
The health regulator requires patients on rival Eli Lilly's Alzheimer's drug Kisunla to obtain a brain MRI prior to the second, third, fourth and seventh infusions.
Biogen's Leqembi was approved in 2023 to slow the progression of Alzheimer's disease in patients with mild cognitive impairment or mild dementia stage of disease.
It targets an underlying cause of the fatal mind-wasting disease.
An injectable version of the drug, currently given by intravenous infusion, is under U.S. regulatory review.
Reporting by Sriparna Roy in Bengaluru; Editing by Alan Barona
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