The U.S. Food and Drug Administration
The U.S. Food and Drug Administration
Photo: AP
The U.S. Food and Drug Administration

Eli Lilly's antibody combination receives FDA emergency use authorization for COVID-19

Lilly's combination therapy of two antibodies, bamlanivimab and etesevimab, helped cut the risk of hospitalization and death in COVID-19 patients by 70%, data from a late-stage trial showed in January

Reuters |
Published: 02.10.21 , 07:46
Eli Lilly's combination antibody therapy to fight COVID-19 has been granted emergency use authorization by the U.S. Food and Drug Administration, Lily said on Tuesday.
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  • Lilly's combination therapy of two antibodies, bamlanivimab and etesevimab, helped cut the risk of hospitalization and death in COVID-19 patients by 70%, data from a late-stage trial showed in January.
    2 צפייה בגלריה
    The U.S. Food and Drug Administration
    The U.S. Food and Drug Administration
    The U.S. Food and Drug Administration
    (Photo: AP)
    Lilly said the therapy will be available immediately. "There are 100,000 doses ready immediately and an additional 150,000 doses will be available throughout the first quarter," Lilly said in a statement.
    The company said that in collaboration with Amgen, it plans to manufacture up to 1 million doses of etesevimab for administration with bamlanivimab by mid-2021.
    Lilly said the "therapy 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.
    2 צפייה בגלריה
    טיפול בחולי קורונה בית חולים ב קליפורניה ארה"ב
    טיפול בחולי קורונה בית חולים ב קליפורניה ארה"ב
    A coronavirus ward in a California ospital
    (Photo: AFP)
    "The FDA, separately, said bamlanivimab and etesevimab are not authorized for patients hospitalized due to COVID-19 or who require oxygen therapy due to COVID-19.
    Late last month, Lilly reported a fourth-quarter profit that topped Wall Street estimates. It recorded $871.2 million in quarterly sales of the COVID-19 therapy bamlanivimab, benefiting from the U.S. government's move to stock up on the drug for emergency use.
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