Eisai/Biogen’s Leqembi: US FDA’s Full Approval Comes With A Boxed Warning On ARIA Risk

07 Jul 2023

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.

Black box — Leqembi's regular approval came with a proverbial "black box" warning on ARIA risks. • Source: Shutterstock

The US Food and Drug Administration’s conversion from accelerated to regular approval of Eisai Co., Ltd. and Biogen, Inc.’s Alzheimer’s drug Leqembi (lecanemab-irmb) comes with amped up safety information in the product label, including a new boxed warning on amyloid-related imaging abnormalities and stronger recommendations for pretreatment genetic testing.

On 6 July, the FDA granted full approval to lecanemab, making it the first amyloid beta-directed antibody – and the...