Three Strikes, But Not Out Yet, Lilly’s Donanemab Approval Delayed Again

Accelerated Approval Snub Was More Than A Year Ago

The US FDA wants to hold an advisory committee meeting for Lilly’s donanemab in early Alzheimer’s disease, which means approval will now occur after the expected Q1 decision date.

Brain Xray
Donanemab safety and efficacy both are likely topics for the Adcomm • Source: Shutterstock

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