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www.fdanews.com/articles/202093-hhs-restricts-use-of-eli-lillys-monoclonal-antibody-bamlanivimab-due-to-covid-variant-resistance

HHS Restricts Use of Eli Lilly’s Monoclonal Antibody Bamlanivimab Due to COVID Variant Resistance

March 29, 2021

Just four months after Eli Lilly’s COVID-19 antibody therapy, bamlanivimab, received FDA Emergency Use Authorization (EUA), HHS is restricting nationwide distribution of it due to concerns about an increase in variants of SARS-CoV-2 that are resistant to the drug.

HHS said that other monoclonal antibodies approved for use against COVID-19 won’t be affected, including Lilly’s combination antibody therapy, bamlanivimab and etesevimab, which just got its EUA last month, and Regeneron Pharmaceuticals‘ antibody cocktail, casirivimab and imdevimab (DID, March 16).

The HHS announcement follows the department saying in mid-March that it would stop distributing bamlanivimab in California, Arizona and Nevada — states that were seeing multiple cases of infection with the mutated SARS-CoV2 virus — because of worries over the antibody’s ineffectiveness against variants.

In early March, Eli Lilly disclosed that the combo therapy of bamlanivimab and etesevimab reduced the risk of hospitalization and death from COVID-19 by 87 percent in a phase 3 study and was effective against emerging variant strains of the coronavirus. — Suz Redfearn