Lilly’s Gets FDA Adcomm on Approval of Alzheimer’s Drug Donanemab

Rather than handing out the approval Lilly was hoping for, the FDA will put donanemab, the company’s antiamyloid contender to treat Alzheimer’s disease, through its paces in an upcoming advisory committee meeting.

The agency wants to dig into donanemab’s safety record, its limited dosing regimen, which allows patients to stop treatment after amyloid plaques clear, and its potential relationship to tau, the other abnormal protein present in Alzheimer’s disease, the company said.  

While the deferral is a disappointment, Lilly stands by donanemab’s phase 3 data, according to Anne White, executive vice president of Lilly, and president of Lilly Neuroscience.

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