Roche confirmed positive data from the phase II/III 2066 study, investigating Ronapreve (casirivimab and imdevimab) in patients hospitalized with COVID-19. The trial met its primary endpoint, showing significantly reduced viral load within seven days of treatment in patients who had not mounted a natural antibody response and who required low-flow or no supplemental oxygen.
The study also reported clinical results supportive of the larger UK RECOVERY trial in hospitalized patients showing that patients who received Ronapreve (2,400 mg or 8,000 mg) in addition to standard-of-care experienced numeric improvements across all clinical endpoints assessed, compared to standard of care alone (placebo). Comparable clinical outcomes were recorded with both 2,400 mg and 8,000 mg doses. No new safety signals were identified.
The efficacy and safety of Ronapreve have been studied across multiple phase III clinical trials in non-hospitalized and hospitalized COVID-19 patients, and in the preventive setting. Ronapreve is currently not authorized in patients who are hospitalized due to COVID-19 infection. Earlier this year, the EMA issued a scientific opinion supporting the use of Ronapreve as a treatment option for non-hospitalized patients with confirmed COVID-19. Ronapreve has been approved for use in different patient populations in Japan and conditionally in the UK, and is authorized for emergency use in the U.S., India and Canada.
About the REGN-COV 2066 study
The phase II/III, randomized, double-blind, placebo-controlled trial evaluated Ronapreve in hospitalized adult patients with COVID-19. Patients were randomized 1:1:1 to receive a one-time infusion of Ronapreve 8,000 mg, Ronapreve 2,400 mg or placebo. All patients entering the trial received other background standard-of-care as required including corticosteroids (75%) and remdesivir (55%).
About Ronapreve
Ronapreve™ (casirivimab and imdevimab) is being jointly developed by Roche and Regeneron. It is a combination of two monoclonal antibodies, casirivimab and imdevimab (also known as REGN10933 and REGN10987), and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
The study also reported clinical results supportive of the larger UK RECOVERY trial in hospitalized patients showing that patients who received Ronapreve (2,400 mg or 8,000 mg) in addition to standard-of-care experienced numeric improvements across all clinical endpoints assessed, compared to standard of care alone (placebo). Comparable clinical outcomes were recorded with both 2,400 mg and 8,000 mg doses. No new safety signals were identified.
The efficacy and safety of Ronapreve have been studied across multiple phase III clinical trials in non-hospitalized and hospitalized COVID-19 patients, and in the preventive setting. Ronapreve is currently not authorized in patients who are hospitalized due to COVID-19 infection. Earlier this year, the EMA issued a scientific opinion supporting the use of Ronapreve as a treatment option for non-hospitalized patients with confirmed COVID-19. Ronapreve has been approved for use in different patient populations in Japan and conditionally in the UK, and is authorized for emergency use in the U.S., India and Canada.
About the REGN-COV 2066 study
The phase II/III, randomized, double-blind, placebo-controlled trial evaluated Ronapreve in hospitalized adult patients with COVID-19. Patients were randomized 1:1:1 to receive a one-time infusion of Ronapreve 8,000 mg, Ronapreve 2,400 mg or placebo. All patients entering the trial received other background standard-of-care as required including corticosteroids (75%) and remdesivir (55%).
About Ronapreve
Ronapreve™ (casirivimab and imdevimab) is being jointly developed by Roche and Regeneron. It is a combination of two monoclonal antibodies, casirivimab and imdevimab (also known as REGN10933 and REGN10987), and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
