Sunday, November 22, 2020

FDA & monoclonal antibody treatment for COVID-19

 Recently, the FDA issued an emergency use authorization for casirivimab and imedimab (to be used together) in order to treat cases of mild-moderate COVID-19, for adults and children 12+. Trials were hopeful, and with administration of both drugs, there were a reduction of COVID-19 hospitalizations/emergency room visits (related to COVID), in comparison to the placebo. The trial and the data based on this trial note that under double-blind, placebo-control in 799 non-hospitalized adults with mild-moderate COVID-19 symptoms, two groups of 266 and 267 received one infusion of monoclonal antibody treatment (1,200mg and 8,000 mg, respectively) and 266 received the placebo, within 3 days of getting a positive SARS-CoV-2 test.

The FDA notes that these drugs are not advised to those who are hospitalized, or anyone on oxygen therapy - as no positive benefits have been seen with these issues. 

The FDA also explains that casirivimab and imdevimab are monoclonial antibodies that are directed against the SARS-CoV-2 spike proteins - blocking attachnment/entry into human cells.

- Justin 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19

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