Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023.
Eli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker's experimental Alzheimer's treatment donanemab in a surprise move.
The agency plans to call a last-minute meeting of its outside advisors to further review the treatment's safety and efficacy in a late-stage trial, Eli Lilly said.
It's another setback for Eli Lilly, which is racing to compete with Biogen and Eisai.
In 2021, the FDA approved an earlier, ill-fated Alzheimer's drug called Aduhelm from Biogen and Eisai, despite a negative recommendation from the agency's advisory panel.
Persons:
Eli Lilly, Eli Lilly's, Leqembi, Anne White
Organizations:
and Drug Administration, FDA
Locations:
Indianapolis , Indiana, Biogen