FDA Issues EUA for Casirivamab + Imdevimab Antibodies to Treat COVID-19

On November 21, 2020, the U.S. Food and Drug Administration (FDA) announced its second emergency use authorization (EUA) for monoclonal antibodies to treat COVID-19. Under the EUA, casirivamab and imdevimab must be administered together by intravenous use for the treatment of mild to moderate COVID-19 in adults and pediatric patients who:

• Are 12-years-old or older
• Weigh at least 40 kilograms (about 88 pounds)
• Have positive results of direct SARS-CoV-2 viral testing
• Are at 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.

When administered together in patients with COVID-19 via clinical trial, casirivamab and imdevimab reduced COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. A benefit has not been shown in patients hospitalized due to COVID-19. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.

Read the FDA announcement.

Posted 11/23/2020