Ronapreve® (casirivimab/imdevimab), Solution for injection/infusion, 120 mg/mL

Swissmedic marketing authorisation number: 68329

Swissmedic marketing authorisation date: 23.12.2021


Indication: Treatment of COVID-19

Phase: III

Summary: COV-2067 is a randomized, double-blinded, placebo-controlled clinical trial evaluating Ronapreve (casirivimab and imdevimab) for the treatment of symptomatic adult subjects with RT-qPCR confirmed COVID-19 who are not hospitalized or requiring supplemental oxygen

Sponsor: Regeneron Pharmaceuticals


Indication: Prevention of COVID-19

Phase: III

Summary: COV-2069 was a randomised, double-blind, placebo-controlled clinical trial that compared 600 mg casirivimab and 600 mg imdevimab given subcutaneously to placebo for prevention of COVID-19 in asymptomatic household contacts of symptomatic individuals infected with SARS-CoV-2 (index cases). 

Sponsor: Regeneron Pharmaceuticals


  1. Weinreich DM et al. REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19. N Engl J Med. Sept. 29, 2021; 384: 238-251. DOI: 10.1056/NEJMoa2108163

  2. O’Brien MP et al. Subcutaneous REGEN-COV antibody combination to prevent Covid-19. N Engl J Med. August 04, 2021; DOI:10.1056/NEJMoa2109682

  3. O’Brien M.P. et al. Subcutaneous REGEN-COV Antibody Combination in Early Asymptomatic SARS-CoV-2 Infection: A Randomized Clinical Trial. Posted September 18, 2021 on medRxiv. DOI:

Publication of clinical trial results
The above information and the links provided to clinical data comply with the requirements of Articles 71-73 of the Ordinance on Medicinal Products (VAM) and complement the information published in connection with the Swiss marketing authorisation of Ronapreve. Articles 71-73 VAM apply to all medicinal products submitted and authorised by Swissmedic as of January 2019. 
The published data supports physicians and other healthcare providers in making informed treatment decisions and allows researchers to more easily base their research on that conducted by Roche and its partners, as well as that conducted by other researchers, in order to drive scientific progress.

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