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Leqembi Safety: Label Has Distinct MRI Schedule But Follows Aduhelm On ARIA Management

 
• By Sue Sutter

With the second amyloid-targeting antibody for treatment of Alzheimer’s, US FDA opted for a class-wide approach to management of amyloid-related imaging abnormalities, but with a product-specific MRI monitoring schedule that differs from that of Aduhelm.

Drug Review Profile: Leqembi
Leqembi and Aduhelm carry different schedules for MRI monitoring for ARIA. • Source: Pink Sheet/Shutterstock

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...

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