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REGEN-COV™ (casirivimab and imdevimab) Phase 3 RECOVERY Trial Meets Primary Outcome, Improving Survival in Hospitalized COVID-19 Patients Lacking an Immune Response to SARS-CoV-2
TARRYTOWN, N.Y., June 16, 2021 /PRNewswire/ -- UK RECOVERY investigators found REGEN-COV reduced risk of death by 20% in patients hospitalized with COVID-19
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y., June 16, 2021 /PRNewswire/ -- \nUK RECOVERY investigators found REGEN-COV reduced risk of death by 20% in patients hospitalized with COVID-19 who had not mounted their own immune response (primary outcome for the primary analysis population)\nFirst trial to demonstrate that any antibody treatment improved survival in patients hospitalized with COVID-19 \nRegeneron will share new data with regulatory authorities immediately and request that the U.S. EUA be expanded to include appropriate hospitalized patients\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today welcomed positive results from the largest trial assessing any monoclonal antibody treatment in patients hospitalized with severe COVID-19. The UK RECOVERY trial found that adding investigational REGEN-COV™ to usual care reduced the risk of death by 20% in patients who had not mounted a natural antibody response on their own against SARS-CoV-2, compared to usual care on its own.\n\"These results are very exciting. The hope was that by giving a combination of antibodies targeting the SARS-CoV-2 virus we would be able to reduce the worst manifestations of COVID-19,\" said Sir Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and Joint Chief Investigator for the RECOVERY trial. \"There was, however, great uncertainty about the value of antiviral therapies in late-stage COVID-19 disease. It is wonderful to learn that even in advanced COVID-19 disease, targeting the virus can reduce mortality in patients who have failed to mount an antibody response of their own.\"\nRECOVERY is the first trial large enough to definitively determine whether REGEN-COV reduces mortality in patients hospitalized with severe COVID-19. Previous Phase 3 trials in non-hospitalized COVID-19 patients have shown that REGEN-COV reduced viral levels, shortened the time to resolution of symptoms and significantly reduced the risk of hospitalization or death. In a Phase 1/2 trial in hospitalized patients, REGEN-COV also rapidly reduced viral levels, with preliminary evidence suggesting that it lowered the risk of death or receiving mechanical ventilation, with the benefit driven by patients who entered the trial without having mounted a natural antibody response of their own (seronegative); and in the absence of REGEN-COV tre...