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
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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.
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The FDA did not require a postmarketing clinical trial on safety, but Lilly agreed to a clinical study assessing maintenance dosing after amyloid plaque clearance
Donanemab became the third approved product in the anti-amyloid monoclonal antibody class after the FDA’s 2 July clearance
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