The US government and Eli Lilly agreed to halt all distribution of the company’s Covid-19 monoclonal antibody bamlanivimab as of Wednesday due to the “sustained increase” of coronavirus variants in the US.
All treatment delivery sites will continue to be able to order Lilly’s combo Covid-19 treatment of bamlanivimab and etesevimab, to be administered together, or Regeneron’s antibody cocktail, the assistant secretary for preparedness and response (ASPR) and FDA said. Both of the treatments from Lilly and Regeneron have proven to be useful among people who have Covid-19 but are not hospitalized.
“We recognize the U.S. government has made the decision to no longer allow direct ordering of bamlanivimab alone due to concerns about the prevalence of the California (B.1.427/B.1.429) and New York (B.1.526) variants of SARS-CoV-2. The U.S. government has enabled direct ordering of bamlanivimab and etesevimab together as well as etesevimab alone, to pair with bamlanivimab that sites of care have on hand,” Lilly said in an emailed statement to Endpoints News.
Lilly, in collaboration with Amgen, plans to manufacture up to 1 million doses of etesevimab for administration with bamlanivimab by mid-2021.
The shift comes as the US had halted all shipments of bamlanivimab alone to three western states last week due to coronavirus variants. The FDA last week also updated its three fact sheets on the monoclonal antibody treatments from Eli Lilly and Regeneron, offering new data to show how susceptible bamlanivimab alone is to some of the SARS-CoV-2 variants originating in the UK, Brazil, South Africa, California and New York.
“Using an alternative authorized monoclonal antibody therapy may reduce the risk of treatment failure should a patient be infected with a SARS-CoV-2 viral variant that is resistant to bamlanivimab alone,” the US advised physicians.
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