COVID Antibody Products May Get To Use Viral Load As Surrogate For Mutant-Targeted Versions
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.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Top-line Phase II data show that a combo of bamlanivimab and VIR-7831, neutralizing antibodies to the SARS-CoV-2 spike protein, yielded a relative 70% reduction in viral load.
The doses of bamlanivimab and etesevimab authorized for use in combination are a fraction of those shown to be effective in the Phase III BLAZE-1 trial; however, Phase II data, PK/PD modeling and in vitro data suggest the lower doses will have the same clinical impact as the higher-dose regimen, the FDA said.