RONAPREVE Injection (Casirivimab and Imdevimab)

Casirivimab and imdevimab are human, non-competing, high-affinity, IgG1 (immunoglobulin G1)-neutralising monoclonal antibodies produced by recombinant DNA technology and are to be administered together either intravenously or subcutaneously.  Each antibody targets a different region of the S-proteins of SARS-CoV-2 and, hence, prevents interaction of the S-proteins with the ACE-2 receptors, leading to inhibition of infectivity of the host cells.

Casirivimab and imdevimab were investigated in a double-blind, Phase 1/2/3 trial involving non-hospitalised patients with COVID-19. The outcome of the Phase 3 part of this trial in 4,567 patients was subsequently reported in March 2021.  A 70.4% reduction in the number of patients with a COVID-19-related hospitalisation or all-cause death was observed with both the 2,400 mg and the 1,200 mg dose of REGN-COV2 (Casirivimab and Imdevimab). The efficacy and safety of both doses of casirivimab and imdevimab were comparable.

From the currently available safety information, there are no major safety concerns. In vitro and animal studies confirm that the efficacy of casirivimab and imdevimab is not impacted by the novel viral variants, including the B.1.1.7 (UK origin), B.1.351 (South Africa origin), P.1 (Brazil origin), B.1.427/B.1.429 (California origin), B.1.526 (New York origin), and the B.1.617/B.1.618 (India origin). 

During the supporting clinical study, positive efficacy was observed in conjunction with an acceptable safety profile, thus demonstrating a favourable benefit-risk assessment for treatment with the casirivimab and imdevimab combination. The known and potential benefits of the RONAPREVE (casirivimab and imdevimab combination), when used to treat documented SARS-CoV-2 infection in patients at high risk of COVID-19 complications, outweigh the known and potential risks.

Casirivimab and imdevimab are human, non-competing, high-affinity, IgG1 (immunoglobulin G1)-neutralising monoclonal antibodies produced by recombinant DNA technology and are to be administered together either intravenously or subcutaneously.  Each antibody targets a different region of the S-proteins of SARS-CoV-2 and, hence, prevents interaction of the S-proteins with the ACE-2 receptors, leading to inhibition of infectivity of the host cells.

Casirivimab and imdevimab were investigated in a double-blind, Phase 1/2/3 trial involving non-hospitalised patients with COVID-19. The outcome of the Phase 3 part of this trial in 4,567 patients was subsequently reported in March 2021.  A 70.4% reduction in the number of patients with a COVID-19-related hospitalisation or all-cause death was observed with both the 2,400 mg and the 1,200 mg dose of REGN-COV2 (Casirivimab and Imdevimab). The efficacy and safety of both doses of casirivimab and imdevimab were comparable.

From the currently available safety information, there are no major safety concerns. In vitro and animal studies confirm that the efficacy of casirivimab and imdevimab is not impacted by the novel viral variants, including the B.1.1.7 (UK origin), B.1.351 (South Africa origin), P.1 (Brazil origin), B.1.427/B.1.429 (California origin), B.1.526 (New York origin), and the B.1.617/B.1.618 (India origin). 

During the supporting clinical study, positive efficacy was observed in conjunction with an acceptable safety profile, thus demonstrating a favourable benefit-risk assessment for treatment with the casirivimab and imdevimab combination. The known and potential benefits of the RONAPREVE (casirivimab and imdevimab combination), when used to treat documented SARS-CoV-2 infection in patients at high risk of COVID-19 complications, outweigh the known and potential risks.

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