The Food and Drug Administration has decided to delay action on a closely watched Alzheimer’s drug, donanemab, which the agency was widely expected to approve this month.
will instead require donanemab to undergo the scrutiny of a panel of independent experts, the drug’s maker, Eli Lilly and Company, said Friday.
The decision is likely to surprise many Alzheimer’s experts, doctors and patients who had expected the medication would soon be on the market.
The F.D.A.’s move was startling to the company, which had been planning for the agency to greenlight the drug during the first quarter of this year.
“We were not expecting this,” Anne White, an executive vice president of Lilly and president of its neuroscience division, said in an interview.
Persons:
Eli Lilly, “, Lilly, ” Anne White, ”
Organizations:
Drug Administration
Locations:
donanemab