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European Commission approved Roche's and Celltrion's monoclonal antibodies for COVID19

  • Ronapreve (casirivimab / imdevimab) approved for treating and preventing COVID19 in adults and adolescents

  • Celltrion's Regkirona (regdanvimab) is approved for treating COVID19

Ronapreve (casirivimab / imdevimab):

Roche announced that the European Commission approved Ronapreve for treating COVID19 patients at risk of developing severe disease and preventing COVID19 in adults and adolescents. The drug is indicated in patients who are not on oxygen support.

The drug is a combination of casirivimab and imdevimab.

The approval is based on two trails:

  • REGN-COV 2067 - Treatment study in non-hospitalized patients: Risk of hospitalization or death decreased by 70%

  • REGN-COV 2069 - Prophylaxis study: Risk of infection was reduced by 81%

Ronapreve was developed in collaboration between Roche and Regeneron.

Regkirona (regdanvimab)

Celltrion announced that European Commission approved Regkirona for treating adults with COVID19 patients. The drug is indicated for patients who do not require supplemental oxygen and are at risk of developing severe disease.

The approval is based on a Phase III trial which enrolled 1,315 patients. The rate of hospitalization or death was decreased by 72%.

The drug is approved in South Korea; Brazil and Indonesia gave emergency use authorization; the company is in discussions with the FDA for emergency use authorization.


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