The FDA on Thursday afternoon updated its three fact sheets on the monoclonal antibody treatments from Eli Lilly and Regeneron, offering new data on the susceptibility of the SARS-CoV-2 variants originating in the UK, Brazil, South Africa, California and New York to each of the mAb therapies.
“Some variants can cause resistance to one or more of the mAb therapies authorized to treat COVID-19,” FDA said. “Health care providers should review the authorized fact sheets for information on the use of the authorized mAb therapies against currently circulating viral variants.”
For Lilly’s bamlanivimab alone, which is no longer being distributed by the US government in California, Nevada and Arizona because of the variant originating in California, the FDA noted in its revised fact sheet major reductions in susceptibility for all of the variants studied, except for the one originating in the UK. Almost 800,000 courses of bamlanivimab have now been distributed across the US, including more than 100,000 courses to California, Nevada and Arizona.
But for Lilly’s combination therapy of bamlanivimab and etesevimab, the updated fact sheet showed the treatment fared better against all of the variants than bamlanivimab alone. A Lilly spokesperson said in a statement: “It has always been our view that additional antibodies from Lilly and others will need to be developed to address the evolution of the virus, including emerging variants that can differ by country or even by state. In fact, this is what drove our work on bamlanivimab and etesevimab together and continues to underpin our strategy moving forward.”
And Regeneron’s mAb combination of casirivimab with imdevimab showed the least reduction in susceptibility against the variants, according to its updated fact sheet. Through Feb. 2, the US says it’s allocated 148,022 doses of the Regeneron mAb cocktail.
“FDA is required to regularly review the circumstances and appropriateness of an EUA, and the agency continues to review emerging scientific information associated with the emergency uses for the authorized mAb products, including information on viral variants,” the agency said in a statement. “FDA is committed to providing updated information on variants and their potential impact on the authorized mAb therapies as new information becomes available.”
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