FDA Grants Emergency Use Authorization for Regeneron

For Immediate Release:

November 21, 2020

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.

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

>>11732304

Twat version of the press release:

U.S. FDA @US_FDA·1h

Today, we issued an emergency use authorization (EUA) for two monoclonal antibodies to be administered together for the treatment of mild to moderate #COVID19 in high-risk adults and pediatric patients age 12 and older.

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

Monoclonal antibodies are lab-made proteins that mimic the immune system’s ability to fight off pathogens such as viruses. The EUA is for antibodies specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.

In a clinical trial, the investigational therapy was shown to reduce COVID-19-related hospitalization or ER visits in certain patients who are at high risk for progressing to severe #COVID19.

https://twitter.com/US_FDA/status/1330311880615845888

>>11732404

>>11732304

Looks like FDA has a tweeter account just for Drug information. This account actually posted the information first.

https://twitter.com/FDA_Drug_Info/status/1330309938149781511