Former US FDA commissioners say that data for Lilly and Regeneron’s authorized mABs suggesting that reduced viral load correlates with clinical benefit potentially paves the way for emergency authorization or accelerated approval of mABs specifically designed to target emerging variants of the SARS-CoV-2 virus.
The use of viral load reduction as a surrogate marker could help expedite changes in monoclonal antibodies aimed at tackling emerging variants of the SARS-CoV-2 virus.
During a 16 February meeting sponsored by the Duke-Margolis Center for Health Policy, former FDA commissioner Scott Gottlieb described policy...