FDA Delays Decision on Lilly's Alzheimer's Drug Donanemab, Seeks Advisory Review of Safety and Efficacy Data

• Lilly's stock declined as FDA delays decision on Alzheimer's drug donanemab until an advisory committee reviews safety and efficacy data • Donanemab significantly slowed cognitive and functional decline in early Alzheimer's patients in late-stage study • Incidence of brain swelling side effect ARIA was 24% with donanemab vs 13.6% for placebo • FDA previously rejected donanemab's accelerated approval application in 2021 due to limited data • Anti-amyloid beta antibodies like donanemab expect to show efficacy in early Alzheimer's, though uptake has been slow for approved drugs