Eisai/Biogen’s Leqembi: US FDA’s Full Approval Comes With A Boxed Warning On ARIA Risk
Executive Summary
Labeling for the first anti-amyloid to receive traditional approval in Alzheimer’s disease states that testing for ApoE ε4 status ‘should be performed’ prior to treatment; updated labeling also includes stronger cautionary language on use in patients with risk factors for cerebral hemorrhage.
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