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Anti-Amyloid Class Labeling Could See Changes With Lilly’s Donanemab Approval

 
• By Sue Sutter

The US FDA is considering labeling that calls greater attention to the symptoms of amyloid-related imaging abnormalities to ensure proper treatment and avoid misclassification as ischemic stroke.  

Alzheimers imaging
ARIA symptoms in Alzheimer's patients may mimic the signs of ischemic stroke. • Source: Shutterstock

The US Food and Drug Administration’s review and expected approval of Eli Lilly and Company’s donanemab could lead to another safety labeling update for the class of anti-amyloid therapies in Alzheimer’s disease.

The agency is considering requiring that labeling and other materials call greater attention to the symptoms of amyloid-related imaging abnormalities (ARIA) among patients taking the monoclonal antibodies to

Key Takeaways

  • The FDA is considering changes to anti-amyloid class labeling that would indicate ARIA can present with symptoms that mimic stroke.

  • Lilly proposes giving patients information cards that can be presented to attending physicians in the event of ARIA symptoms

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