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A Lesson In Confidence Amid Development Hurdles: How Lilly Has Talked About Donanemab

 
• By Derrick Gingery

The Alzheimer’s disease candidate’s positive milestones, and even its review delays, continue to produce confident statements in its future from the sponsor.

Alzheimer's disease
Donanemab will require an advisory committee meeting before the FDA makes a decision on the application. • Source: Shutterstock

Eli Lilly and Company’s Alzheimer’s treatment donanemab has inspired confidence throughout its development, even from US Food and Drug Administration Commissioner Robert Califf, despite development setbacks.

The latest hurdle is the FDA’s decision to consult the Peripheral and Central Nervous System Drugs Advisory Committee, which will extend the goal date for a final decision on the...

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