FDA rescinds EUA for solo use of Lilly's bamlanivimab
The combination monoclonal antibody treatment of bamlanivimab and etesevimab still OK.
Soon after Eli Lilly & Co. asked the FDA to do so, the agency rescinded its emergency use authorization (EUA) for the monoclonal antibody bamlanivimab to be used by itself when treating COVID-19 due to new variants' resistance to the treatment.
“Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use,” the agency said in a press release.
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Lilly said in a press release that it requested FDA rescind the use of bamlanivimab alone as part of its transition to only supply bamlanivimab and etesevimab for administration together, as planned with the FDA. The final step “follows the modification of contracts with the U.S. government to ensure adequate supply of etesevimab to be used together with bamlanivimab,” Lilly said.
"With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” said Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories.
All sites in the U.S. now have access to obtain doses of etesevimab for administration with bamlanivimab—which together neutralize more of the emerging COVID-19 variants in the U.S. than bamlanivimab alone, Lilly said.
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“In the U.S., bamlanivimab alone should no longer be administered. However, sites of care should not dispose of bamlanivimab supply; instead, they should order etesevimab to pair with it,” Lilly said.
Bamlanivimab was the first neutralizing monoclonal antibody to receive EUA from the FDA as a treatment for mild to moderate COVID-19, “providing a valuable treatment at a time when cases were at their highest in the U.S.,” Lilly said.
More than 400,000 patients have been treated with bamlanivimab — more than any other neutralizing antibody — potentially preventing more than 20,000 hospitalizations and at least 10,000 deaths, according to the pharmaceutical manufacturer.
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