FDA Made the Right Call on Lilly’s Donanemab, Some Experts Say

January 24, 2023

Thursday, the FDA rejected Eli Lilly’s Alzheimer’s disease candidate, donanemab, an investigational antibody to ameliorate the symptoms of Alzheimer’s disease (AD). While the news may have disappointed the company, some AD experts asserted the FDA’s actions were appropriate. What’s more, Lilly’s approach with donanemab is misdirected, critics suggested.

Because donanemab works chiefly to remove plaques in the brain, without benchmarking efficacy, such as improved function, quality of life and independence for AD patients, it doesn’t portend any real progress for patients, Sharon L. Rogers, Ph.D., CEO of AmyriAD and long-time AD specialist told BioSpace.

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