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Eli Lilly said Thursday that U.S. regulators had rejected its application seeking accelerated approval for donanemab, a treatment for people with early stage Alzheimer’s disease.

Despite the setback, Lilly said that the planned readout from an ongoing, Phase 3 study of donanemab remains on track for the middle of the year, and if positive, will form the basis of an application for full approval “shortly thereafter.”


Lilly had filed for accelerated approval based on a mid-stage study that showed donanemab lowered levels of amyloid, a toxic protein in the brain thought to drive the advance of Alzheimer’s. This is the same regulatory standard that Biogen used successfully to win a controversial accelerated approval for Aduhelm. Earlier this month, the FDA also granted accelerated approval to Eisai for its Alzheimer’s treatment, called Leqembi, based on the drug’s ability to decrease levels of toxic amyloid.

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