Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the New England Journal of Medicine(NEJM) published positive detailed results from a Phase 3 trial that assessed the ability of REGEN-COV™ (casirivimab and imdevimab) 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.
"This peer-reviewed NEJM publication demonstrates that REGEN-COV provides rapid and robust protection to prevent SARS-CoV-2 infection, and follows data showing that REGEN-COV maintains effectiveness against all variants of concern," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "Despite the increased uptake of vaccines, SARS-CoV-2 has not been eradicated. In addition, growing evidence suggests that a substantial number of individuals, such as the immunocompromised, will not respond satisfactorily to vaccines. Thus, we believe there is a significant need for complementary medicines such as REGEN-COV to help prevent the spread of SARS-CoV-2 infection, particularly in these immunocompromised patients."
Regeneron previously announced initial results from the Phase 3 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).
The robust REGEN-COV development program has reported positive Phase 3 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 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
REGEN-COV use is increasing across the U.S. following the latest surge, with recent weekly orders surpassing 50,000 doses. In addition to the increasing proportion of patients who now receive REGEN-COV, Regeneron continues to work to ensure all medical supply providers and people who may benefit from this important therapy are aware of its availability.
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