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

Accelerated Approval Snub Was More Than A Year Ago

 
• By Mandy Jackson

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

US Food and Drug Administration approval for Eli Lilly and Company’s donanemab has been delayed for a third time now that the agency has decided to convene a meeting of its Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase III TRAILBLAZER-ALZ 2 trial results for the anti-amyloid antibody in early Alzheimer’s disease. Lilly expected approval during the first quarter of 2024 but said on 8 March that this is no longer likely.

Key Takeaways

  • After the US FDA declined to grant accelerated approval for Lilly’s donanemab and pushed out the action date for potential full approval last year, the agency again delayed its decision because it wants to convene an advisory committee meeting.

This is the third time that donanemab’s approval has been pushed back, starting with the FDA’s decision to issue a...

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