Lilly COVID-19 Neutralizing Antibody Combo’s Reduced Infusion Time Offers Advantages For Providers
US FDA's EUA allows lower doses of the two antibodies than were tested in BLAZE-1, which should extend current supply. With Amgen, Lilly hopes to manufacture 1 million doses by mid-year.
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The doses of bamlanivimab and etesevimab authorized for use in combination are a fraction of those shown to be effective in the Phase III BLAZE-1 trial; however, Phase II data, PK/PD modeling and in vitro data suggest the lower doses will have the same clinical impact as the higher-dose regimen, the FDA said.
After disappointing initially, Lilly and Regeneron are back with compelling data for their monoclonal antibody products, but still face challenges from new COVID-19 variants and medical skepticism.