Months after the Food and Drug Administration approved Biogen’s Alzheimer’s drug Aduhelm, Eli Lilly hopes to secure approval for its own similar landmark treatment. But the company’s data came under question by experts in a spirited back-and-forth with Mark Mintun, Lilly’s senior vice-president of neuroscience research and development, at the STAT Summit Thursday.
The pharma giant started filing for accelerated approval from the FDA for its drug, called donanemab, based on a mid-stage study which achieved its primary goal of slowing the rate of cognitive decline compared to a placebo, Mintun said. Like Aduhelm, donanemab works by reducing amyloid plaques in the brain, a biomarker which the FDA established as a new but highly controversial standard for accelerated approval.
But panelists Panelists Maria Glymour, professor of epidemiology and biostatistics at the University of California San Francisco, and Rob Howard, professor of old age psychiatry at University College London, raised concerns that the benefit observed in the Lilly study was too small to be clinically meaningful for patients with Alzheimer’s.
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