MedCity News November 30, 2022
Eisai has presented and published full data from the Phase 3 clinical trial for its Alzheimer’s disease drug lecanemab, with results showing a statistically significant slowing decline associated with the neurodegenerative disorder. While an accelerated approval decision is expected in early 2023, the latest trial data are key because they represent the confirmatory study that could support an application for full FDA approval.
Eisai now has the most detailed look yet at the clinical trial data for its Alzheimer’s disease drug lecanemab, with results showing reductions in telltale disease indicators and a slowing of clinical decline. But the results come amid recent reports of two patient deaths in the study, raising questions about whether the benefits from the drug outweigh...