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For Lilly’s Donanemab, US FDA Commissioner Is Already Thinking About Post-Market Questions

 
• By Sarah Karlin-Smith

From positive topline data to Robert Califf weighing in on the right patient population to treat with the Alzheimer’s candidate in less than a day, the drug rejected by the agency for accelerated approval earlier this year looks to make a quick comeback.

rising sun Alzheimer's
Lilly's donanemab data prompted Califf to discuss the dawning of a new era in Alzheimer's treatments. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

Just hours after Eli Lilly and Company released positive Phase III data for its anti-amyloid Alzheimer’s treatment donanemab on 3 May, US Food and Drug Administration Commissioner Robert Califf was discussing his vision for a new kind of post-market data collection system that could help better pinpoint the people who should be treated with the drug.

It’s unusual for anyone at FDA to be publicly commenting on a drug under development, never mind the commissioner. And it’s particularly interesting given the high-profile and at times controversial nature of the agency’s reviews of this class of medicines

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