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COVID Antibody Products May Get To Use Viral Load As Surrogate For Mutant-Targeted Versions

 
• By Sue Sutter

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.

Footrace
Monoclonal antibody developers and regulators are trying to keep up with changes in the coronavirus that causes COVID-19. • Source: Shutterstock

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 steps needed to ensure that mAB therapeutics are able to...

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More from Pathways & Standards

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EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
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