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