An advisory panel to the FDA recommended Eli Lilly's Alzheimer's drug donanemab on Monday, potentially paving the way for its full approval in the US later this year.
If approved, donanemab will become the second Alzheimer's drug of its kind in the US market, following Leqembi from Biogen and Eisai. The approval could significantly increase treatment options for over six million Americans with Alzheimer's, the fifth-leading cause of death for adults over 65.
The panel's unanimous votes highlighted donanemab's efficacy in early-stage Alzheimer's and its benefits outweighing the risks. However, some advisors called for more data on its effects on Black and Hispanic patients.