Alzheimer’s disease patients in the earliest stages of their disease benefited the most from Eli Lilly drug donanemab, which is expected to receive an FDA decision by the end of 2023. Full results from the drug’s pivotal study were presented during the during the Alzheimer’s Association International Conference.
Patients treated with Eli Lilly Alzheimer’s disease drug donanemab showed a 35% slowing in decline compared to those given a placebo. Based on the Phase 3 results, Lilly said it would seek FDA approval for the drug by the end of June.
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Eli Lilly’s accelerated approval application for its Alzheimer’s disease drug has fallen short. The company said the FDA is asking for data from more patients—results that must come from a larger study that’s underway but won’t report data until later this year.
Experimental Eli Lilly Alzheimer’s drug donanemab is being readied for an FDA submission along the same regulatory path the agency used to approve Biogen’s Aduhelm. Though the Lilly drug met the main goal of a Phase 2 study, it did not show much difference compared to a placebo according to secondary measures of cognition and function.