STAT+: FDA rejects Lilly’s bid for accelerated approval for its Alzheimer’s drug

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.”

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