Regeneron Pharmaceuticals announced that a trial assessing investigational REGEN-COV™ (casirivimab and imdevimab) in patients hospitalized with COVID-19 met its primary endpoint.
REGEN-COV significantly reduced viral load in patients hospitalized with COVID-19 who entered the trial without having mounted their own antibody response (seronegative) and required low-flow or no supplemental oxygen (p=0.0172). The trial also had clinical results supportive of the much larger UK RECOVERY trial in hospitalized patients, with numeric improvements observed across all clinical endpoints assessed.
"COVID-19 continues to have a devastating impact on patients, our communities and healthcare systems, and has so far killed more than one in every 500 Americans," said Eleftherios Mylonakis, M.D., Ph.D., primary investigator of the trial and Professor of Medicine, Molecular Microbiology and Immunology, and Director of Infectious Disease at Brown University and the Lifespan hospitals. "We need a multi-faceted approach to best manage the virus' impact, including vaccination and effective treatment when patients become ill. These data show that REGEN-COV can benefit certain patients even after they are hospitalized, reducing the amount of virus and clinical consequences. Taken together with results announced earlier this year from the RECOVERY trial and other studies, these results have the potential to inform personalized care for hospitalized patients with this protean disease that presents with such high clinical variability."
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 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings. In the U.S., it is not currently authorized in patients who are hospitalized due to COVID-19 infection.
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
- Treatment of certain patients hospitalized due to COVID-19 infection (as detailed in the IDWeek presentation), 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 earlier this month 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.
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