When the US Food and Drug Administration granted accelerated approval to Eisai Co., Ltd. and Biogen, Inc.’s Leqembi (lecanemab-irmb), making it the second amyloid-targeting antibody indicated for Alzheimer’s disease, the agency opted for a class-wide approach to labeling on management of amyloid-related imaging abnormalities, albeit with a product-specific MRI monitoring schedule.
The agency also looked to the labeling of the first comer, Biogen/Eisai’s Aduhelm (aducanumab-avwa), for recommendations regarding continued dosing with lecanemab
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