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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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The trial saw patients given 2800 mg of bamlanivimab and 2800 mg of etesevimab. Among the group given the combination therapy, there were 11 "events," such as hospitalizations, versus 36 "events" recorded in the placebo group, marking a 70% reduction in risk. There were 10 deaths that occurred during the trial, but all involved patients in the placebo group, the company said.
The drugs are monoclonal antibodies, which work best when administered quickly after infection -- within 10 days of symptom onset, Lilly says -- and before patients develop illness requiring hospitalization. Lilly’s drug combo wasn’t authorized to treat hospitalized patients and those in need of oxygen.
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Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said the data backing the authorization "add to emerging evidence that points to the clinical utility of neutralizing antibodies for the treatment of COVID-19 in certain patients."
The drug combo works by blocking the virus from binding to healthy cells.
"Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus," the FDA said in a statement.
Lilly suggested the drug combo could also help combat emerging strains of the virus.
"Lilly has dedicated our time, resources, and expertise to discover and develop therapies to treat COVID-19," Dr. Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Laboratories, said in a company release. "Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit. Additionally, with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world."
Fox News’ Alexandria Hein contributed to this report.
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