FDA greenlights Eli Lilly COVID-19 combo therapy

The drug combo reduced risk of COVID-19 hospitalizations, death by 70% in a clinical trial

The Food and Drug Administration (FDA) on Tuesday issued emergency approval to an Eli Lilly antibody drug combo for high-risk patients recently diagnosed with coronavirus disease.

Bamlanivimab and etesevimab were authorized to treat mild-to-moderate COVID-19 in patients 12 and older weighing at least 88 pounds, testing positive for coronavirus and at-risk of suffering a serious course of COVID-19 disease.

The FDA said a clinical trial of one IV infusion of both drugs resulted in a significant reduction in hospitalizations deaths related to the novel virus in the 29 days of follow-up. Lilly previously announced the drug combo reduced the risk of hospitalization and death in high-risk patients recently diagnosed with coronavirus by 70%. The results stem from a Phase 3 BLAZE-1 trial involving 1,035 patients and add to previous data collected during Phase 2 trials.

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