Paul-Ehrlich-Institut

CHMP Rec­om­mends Au­tho­ri­sa­tion of SARS-CoV-2 Neu­tral­is­ing Mon­o­clon­al An­ti­bod­ies Ron­apreve (casiriv­imab/imde­vimab) and Regkirona (reg­dan­vimab) against COVID-19

On 11 November 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended to the European Commission the marketing authorisation of the monoclonal antibody cocktail Ronapreve (casirivimab/imdevimab) from Roche Registration GmbH and the monoclonal antibody Regkirona (regdanvimab) from Celltrion Healthcare Hungary Kft. Ronapreve and Regkirona are the first monoclonal antibodies for COVID-19 therapy to receive a CHMP recommendation for approval. They belong to the group of SARS-CoV-2 neutralising antibodies. The final decision on authorisation will be made by the European Commission.

Medical Doctor with Model Monoclonal Antibodies (Source: Paulita/Shutterstock.com)

Ronapreve (casirivimab/imdevimab) from Roche Registration GmbH

On 11 October 2021, the EMA had received an application for marketing authorisation from Roche Registration GmbH for the antibody cocktail Ronapreve (casirivimab/imdevimab), jointly developed with Regeneron Pharmaceuticals Inc.

The antibody cocktail will be used to treat COVID-19 patients aged 12 years or older and weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk for a severe course. In addition, Ronapreve can also be used as a preventive measure against COVID-19 disease.

Ronapreve was designed so that the two antibodies it contains attach to the spike protein of SARS-CoV-2 at two different sites. The binding of the antibodies to the spike protein is intended to prevent the virus from entering the body's cells; they are therefore so-called neutralising antibodies.

Regkirona (regdanvimab) from Celltrion Healthcare Hungary Kft

On 4 October 2021, the EMA had received an application for marketing authorisation for the monoclonal antibody Regkirona (regdanivimab) from Celltrion Healthcare Hungary Kft.

Regkirona is intended for the treatment of adults suffering from COVID-19 who do not require oxygen therapy and are also at high risk of severe disease progression.

The monoclonal antibody attaches to the spike protein of SARS-CoV-2, weakening the ability of the virus to enter body cells. This is also a neutralising antibody.

Clinical Trial Results

The CHMP's recommendations for authorisation, in which the Paul-Ehrlich-Institut also evaluates applications, resulted from the analysis of study data that showed that treatment with Ronapreve or with Regkirona significantly reduced both the number of hospitalisations and the number of deaths in COVID-19 patients at risk of a severe course.

Another study showed that Ronapreve can also be used to prevent COVID-19. It reduced the likelihood of getting COVID-19 if a household member was infected with SARS-CoV-2.

Updated: 12.11.2021