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US FDA Authorizes Lilly’s COVID-19 mAB Combo For Lower Doses Than Tested In Phase III

Executive Summary

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.

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