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

 
• By Sue Sutter

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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Lilly's BLAZE-1 trial showed that large mAB doses are effective, but the FDA believes lower doses will have a similar clinical effect. • Source: Shutterstock

A US Food and Drug Administration authorized lower doses of Eli Lilly and Company’s monoclonal antibody cocktail treatment for COVID-19 than were tested in a Phase III trial based, in part, on viral load data from a Phase II study, pharmacokinetic/pharmacodynamic modeling and in vitro data.

Although the doses of bamlanivimab and etesevimab that were authorized for use in combination are a fraction of the doses shown to be effective in the Phase III trial, the lower doses are expected to

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