An Alzheimer’s drug from Biogen and Eisai has received accelerated approval from the Food and Drug Administration, the companies and agency announced Friday.
Warnings for amyloid-related imaging abnormalities and infusion-related reactions appear in Leqembi’s prescribing information.
ARIA "most commonly presents as temporary swelling in areas of the brain that usually revolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain," according to the FDA. The agency said ARIA usually "does not have symptoms, although serious and life-threatening events rarely may occur.
That study also appeared to show the drug helping some to slow decline. In it, about 13% of patients had swelling of the brain and 17% had small brain bleeds.
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