Another monoclonal antibody for early Alzheimer’s sees strong advisory committee support


This week, FDA’s Peripheral and Central Nervous System (PCNS) Advisory Committee met to consider the Eli Lilly’s donanemab as a disease-modifying treatment for early Alzheimer’s disease. The committee weighed unique trial design features and known safety signals, voting unanimously in favor of its risk-benefit profile. Now, potential donanemab approval could curb regulatory uncertainty for the class.

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