US drugmaker Eli Lilly (NYSE: LLY) had expected to hear whether its amyloid plaque-targeting therapy donanemab had been approved in the USA to treat early symptomatic Alzheimer's disease by the end of last year.
But now, after a second delay impacting the US Food and Drug Administration’s (FDA) review of the approval application, the company is unsure of the timing of any decision by the regulator.
"It was unexpected to learn the FDA will convene an advisory committee at this stage"Initially, the FDA pushed back the review time to the end of the first quarter to allow itself more time to consider the application.
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