FDA revises Lilly’s COVID-19 antibody combo EUA for use after exposure to virus
September 16, 2021; 3:55 PM EDT
(Reuters) – The U.S. Food and Drug Administration said on Thursday it has revised its emergency use authorization for Eli Lilly’s (LLY.N) COVID-19 antibody cocktail to include for use in patients who have been exposed to the virus and are at high risk for progression to severe disease.
The cocktail, bamlanivimab and etesevimab, was authorized in February for use in people 12 years and above with mild-to-moderate infection and are at high risk for progression to severe COVID-19.
However, the FDA said on Thursday the cocktail is not a substitute for vaccination against COVID-19. (https://bit.ly/2XqtHln)
The FDA said that bamlanivimab and etesevimab, which are administered together, could be also used as post-exposure prevention for patients who are not fully vaccinated or who are not expected to mount an adequate immune response to complete vaccination or have been exposed to an individual infected with the virus.
The revision comes a day after the U.S. government bought 388,000 additional doses of Lilly’s COVID-19 antibody therapy.
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