Eli Lilly and Company, with US Food and Drug Administration approval on 2 July for Kisunla (donanemab-azbt) for early Alzheimer’s disease, is set to give Eisai Co., Ltd. and Biogen, Inc. a run for their money a year after the partners won full approval of their anti-amyloid antibody Leqembi (lecanemab). Kisunla is dosed less frequently and has a potential cost advantage that may help Lilly rapidly build on the groundwork that Eisai has laid with Leqembi.
Key Takeaways
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The US FDA approved Lilly’s Kisunla (donanemab) for early Alzheimer’s disease, with labeling that allows doctors to end treatment when patients achieve negative amyloid on PET scans.
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With limited duration dosing and infusions every four weeks, even with a higher one-year price than Leqembi, Kisunla may have dosing and cost advantages over the Eisai/Biogen anti-amyloid drug
The list price for Kisunla works out to $32,000 for a year of treatment, which is nearly 21% higher than the $26,500 wholesale acquisition cost (WAC) that Eisai set in January 2023 when the FDA granted accelerated approval for Leqembi. (Also see "Eisai/Biogen’s Leqembi Will Launch Below Aduhelm At $26,500 Per Year" - Scrip, 6 January, 2023.) However, the Lilly product’s label states that prescribers can stop treatment when patients have a negative amyloid PET scan – something achieved by most patients in the Phase III program for donanemab by 18 months – while Leqembi is intended as a continuous treatment
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