The U.S. FDA has issued an Emergency Use Authorization (EUA) for the emergency use of REGEN-COV in adult and pediatric populations (≥12 years of age and older weighing> 40 kg) who are at high risk* of progression to severe COVID-19— including hospitalization or death— and who are not fully vaccinated or are not expected to mount an adequate immune response to the vaccine (eg, immunocompromised state).1 This recommendation is based on a randomized controlled trial involving individuals enrolled within 96 hours of exposure to a known Covid-19 case (Covid-10 Phase 3 Prevention Trial).2
In this trial, the primary efficacy end point was the development of symptomatic SARS-CoV-2 infection through day 28 in participants who did not have SARS-CoV-2 infection by PCR or serology at the time of enrollment. Symptomatic SARS-CoV-2 infection developed in 1.5% of treatment group (vs 7.8% in placebo group) with 81.4% relative risk reduction (P<0.001); 66% reduction was observed when symptomatic and asymptomatic infections were combined. Duration of symptoms and the magnitude and duration of detectable RNA were also lower in the REGEN-COV group compared to placebo. Therapy was well tolerated.2
In the same study, in a subgroup analysis of those who were seropositive at the time of enrollment REGEN-COV lowered the risk of symptomatic disease (0.4% vs 2.3% in the placebo group) with relative risk reduction of 81%, though not statistically significant (P=0.14). This may be why the FDA EUA extended to certain vaccinated groups as well since to date there are no published trials on the use of REGEN-COV as post-exposure prophylaxis in vaccinated individuals.
*High risk group included ≥65 years of age, BMI≥25 kg/m2, diabetes, immunocompromised state, cardiovascular disease or hypertension, chronic lung disease, sickle cell disease and neurodevelopment disorders.
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References
- Fact sheet for health care providers emergency use authorization (EUA) of REGEN-COV. https://www.fda.gov/media/145611/download. Accessed September 15, 2021.
- O’Brien MP. Forleo-Neto E, Musser BJ et al. Subcutaneous REGEN-COV antibody combination to prevent Covid-19. N Engl J Med 2021, August 4, 2021. https://www.nejm.org/doi/full/10.1056/NEJMoa2109682
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