The US Food and Drug Administration (FDA) granted emergency use authorization to Eli Lilly’s antibody treatment to fight coronavirus, the US drugmaker said on Tuesday.
Eli Lilly’s combination therapy of two antibodies, bamlanivimab and etesevimab, is authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization, the company said in a statement.
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The treatment should be administered via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
The FDA emergency authorization was based on trial results which showed that the use of bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70 percent.
“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,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories.
However, bamlanivimab and etesevimab, both separately and together, are not authorized for patients hospitalized due to COVID-19 or who require oxygen therapy due to coronavirus.
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