Benzinga | Sep 29, 2021 05:01PM EDT

New England Journal of Medicine Publishes Phase 3 Trial Results for REGEN-COV (casirivimab and imdevimab) to Treat COVID-19

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(tm) (casirivimab and imdevimab) to treat COVID-19 in infected high-risk non-hospitalized patients (outpatients). The trial met its primary and all secondary endpoints and showed treatment with REGEN-COV significantly reduced the risk of hospitalization or death, with a safety profile consistent with previously reported data.

"Results from this NEJM publication show that REGEN-COV reduced the risk of hospitalization or death by 70% in high-risk non-hospitalized patients infected with COVID-19," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "This peer-reviewed publication further supports the growing evidence on REGEN-COV's critical role to improve outcomes for patients, and reduce the significant burden on their communities and healthcare systems during this COVID-19 pandemic."

REGEN-COV is an investigational medicine authorized by the U.S. Food and Drug Administration (FDA) under an emergency use authorization to treat people who are at high risk of serious consequences from COVID-19, including those who are already infected (non-hospitalized) or those in certain post-exposure prophylaxis settings.

Regeneron previously presented initial results from the Phase 3 trial at the 2021 American Thoracic Society International Conference (ATS 2021). In addition, 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 both uninfected and infected asymptomatic household contacts of SARS-CoV-2 infected individuals

* Treatment of non-hospitalized patients already infected with SARS-CoV-2 (as detailed in today's publication)

* Treatment of certain patients hospitalized due to COVID-19 infection, including the RECOVERY trial

Multiple analyses have shown that the antibody cocktail retains potency against the main variants of concern circulating within the U.S., including Delta (first identified in India), Gamma (first identified in Brazil), Beta (first identified in South Africa) and Mu (first identified in Colombia), with information available in the Fact Sheet for Healthcare Providers. 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.

In the U.S., REGEN-COV is available for free to eligible people, as part of a U.S. government funded program and recently, Regeneron announced a new agreement with the U.S. government to supply an additional 1.4 million 1,200 mg doses of REGEN-COV. Information on how to access REGEN-COV throughout the U.S. is available from the Department of Health and Human Services and the National Infusion Center Association.

The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.