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

BY AMANDA CONTI

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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