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  • Phase III trial of REGEN-COV meets primary endpoin...

Phase III trial of REGEN-COV meets primary endpoint in COVID-19

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Published:6th Aug 2021
Regeneron Pharmaceuticals announced that the New England Journal of Medicine (NEJM) published positive detailed results from a Phase III trial that assessed the ability of REGEN-COV (casirivimab and imdevimab), previously known as REGN-COV2, to prevent COVID-19 infection among household contacts of SARS-CoV-2 infected individuals.

The trial met its primary endpoint, reducing the risk of symptomatic infections by 81% (p<0.001), with a 93% reduction of symptomatic infections after the first week, and no dose-limiting toxicities observed. regeneron previously announced initial results from the phase iii trial, which was jointly run with the covid-19 prevention trials network (covpn) national institute of allergy and infectious diseases (niaid), part of the national institutes of health (nih).></0.001),>

The robust REGEN-COV development program has reported positive Phase III trial results across the spectrum of COVID-19 infection, from prevention to hospitalization: Prevention of symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals (both uninfected contacts as detailed in today's publication, and infected contacts). Treatment of non-hospitalized patients already infected with SARS-CoV-2. Treatment of certain patients hospitalized due to COVID-19 infection, including the RECOVERY trial. In the U.S., REGEN-COV is currently authorized to treat people who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings. Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19 or for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. REGEN-COV has not been approved by the Food and Drug Administration (FDA), but is currently authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency uses.

Multiple analyses, including a recent publication in Cell, have shown that REGEN-COV retains potency against the main variants of concern circulating within the U.S., including Delta (B.1.617.2; first identified in India), Gamma (P.1; first identified in Brazil) and Beta (B.1.351; first identified in South Africa). Consequently, REGEN-COV remains available for use across the U.S., and Regeneron will continue actively monitoring the potency of REGEN-COV against emerging variants.

See: "Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19." Meagan P. O’Brien et al. NEJM August 4, 2021 DOI: 10.1056/NEJMoa2109682

Condition: Coronavirus/COVID-19 Infection
Type: drug

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