The Food items and Drug Administration (Food and drug administration) has licensed the use of REGEN-COV (casirivimab and imdevimab) for postexposure prophylaxis of COVID-19 in men and women (12 decades of age and older weighing at the very least 40kg) who are at superior possibility for development to serious COVID-19, which include hospitalization or dying. The investigational agent was earlier granted Emergency Use Authorization (EUA) for the therapy of moderate to average COVID-19.
REGEN-COV consists of 2 strong, virus-neutralizing antibodies that bind noncompetitively to the receptor binding domain of the SARS-CoV-2 spike protein, therefore blocking its interaction with the host mobile. The evidence supporting the EUA for postexposure prophylaxis of COVID-19 was primarily based on data from the stage 3 COV-2069 demo (ClinicalTrials Identifier: NCT04452318), which enrolled asymptomatic individuals who lived in the similar domestic with a SARS-CoV-2 infected client.
Persons have been randomly assigned to a solitary dose of casirivimab 600mg and imdevimab 600mg (n=753) or placebo (n=752) administered subcutaneously inside 96 hrs of selection of the index cases’ good SARS-CoV-2 diagnostic exam sample. The primary endpoint of the analyze was the proportion of individuals who produced RT-qPCR confirmed SARS-CoV-2 infection via working day 29.
Effects showed that REGEN-COV lowered the possibility of COVID-19 advancement by 81% in the most important assessment population (RT-qPCR detrimental and seronegative at baseline) when compared with placebo (adjusted odds ratio [OR] .17 P <.0001). In a post-hoc analysis, a 62% reduction in risk was observed in the overall trial population (regardless of serology status at baseline) with REGEN-COV vs placebo (adjusted OR 0.35 P <.0001).
For postexposure prophylaxis, the authorized dose of REGEN-COV is casirivimab 600mg and imdevimab 600mg administered together either by subcutaneous injection or intravenous infusion. For individuals who remain at high risk of exposure for longer than 4 weeks, and who are not expected to mount an adequate immune response to COVID vaccination, repeat doses of casirivimab 300mg and imdevimab 300mg once every 4 weeks are appropriate for the duration of ongoing exposure.
Additional information on the use of REGEN-COV for postexposure prophylaxis can be found in the updated fact sheet.
- FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19. News release.. Accessed August 2, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19.
- FDA expands authorized use of REGEN-COV™ (casirivimab and imdevimab). News release.. Accessed August 2, 2021. https://www.prnewswire.com/news-releases/fda-expands-authorized-use-of-regen-cov-casirivimab-and-imdevimab-301345336.html.
- REGEN-COV fact sheet for health care providers. Accessed August 2, 2021. https://www.regeneron.com/downloads/treatment-covid19-eua-fact-sheet-for-hcp.pdf.