In an unusual move, FDA postpones approval decision for Lilly’s Alzheimer’s drug
The Food and Drug Administration has pushed back its approval decision deadline for Eli Lilly’s experimental Alzheimer’s drug donanemab.
The Food and Drug Administration has pushed back its approval decision deadline for Eli Lilly’s experimental Alzheimer’s drug donanemab.
Lilly applied to the FDA for approval of the drug in July, after late-stage clinical trial data showed it slowed the progression of Alzheimer’s by 29% after 18 months, compared to a placebo.
The results were comparable to those seen with Leqembi, a similar Alzheimer’s drug approved by the FDA last year.
The FDA was initially set to decide on donamemab's approval by early next week, according to a source familiar with the agency's planning.
However, in an "unexpected" move, it shifted gears and decided it wants input from its independent advisory committee before making a final decision, Lilly said in a statement Friday.
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