Lilly’s Kisunla Postmarketing Studies Include Maintenance Dosing, But No Safety Trial

 
• By Sue Sutter
  
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Lilly must conduct registry-based and retrospective cohort studies, similar to those required for Eisai/Biogen’s Leqembi, to assess the risks of ARIA and intracerebral hemorrhage with donanemab, but there is no additional requirement for a safety-focused clinical trial.  

Alzheimer's patient
Lilly will assess maintenance dosing with Kisunla. • Source: Shutterstock

The US Food and Drug Administration appears more comfortable with the safety profile of amyloid-directed Alzheimer’s treatments based on the planned postmarketing studies for Eli Lilly and Company’s Kisunla (donanemab-azbt).

Key Takeaways

  • Lilly must conduct registry-based and retrospective cohort studies, similar to those required for Leqembi, to assess Kisunla’s risks of ARIA and intracerebral hemorrhage.

Donanemab became the third approved product in the anti-amyloid monoclonal antibody class after the FDA’s 2 July clearance. (Also see...

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