The FDA granted emergency use authorization Nov. 21 to Regenron’s COVID-19 antibody treatment, a combination of casirivimab and imdevimab.
The phase 3 trial studied the antibody cocktail’s efficacy in 4,567 outpatients. In addition to decreasing the risk of hospitalization and death, analysis showed the treatment shortened the duration of COVID-19 symptoms by four days.
Analysis also showed that the 8,000 milligram dose, 2,400 milligram dose and 1,200 milligram dose shared similar efficacy rates. Regeneron said it will immediately share the new data with regulatory bodies and request that a lower 1,200 milligram dose be added to the antibody cocktail’s FDA emergency use authorization.
The FDA recently updated emergency use authorization fact sheets for all authorized monoclonal antibody treatments and indicated Regeneron’s treatment is the only one to retain its potency against emerging coronavirus variants.
The data Regenron released March 23 have yet to be published in detail or in a peer reviewed journal.
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