EMA Recommends Regeneron-Roche, Celltrion COVID-19 Antibody Treatments

The European Medicines Agency (EMA) has given the thumbs up to two COVID-19 antibody therapies from Regeneron-Roche and Celltrion Healthcare, paving the way for imminent approval by the European Commission.

The therapies ― Regeneron’s and Roche’s Ronapreve (casirivimab and imdevimab), known as REGEN-COV in the U.S., and Celltrion’s Regkirona (regdanvimab) ― both received a positive recommendation by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Specifically, the committee endorsed Ronapreve for treating COVID-19 in people 12 years and older who don’t require supplemental oxygen and who are at increased risk of severe disease, as well as for preventing infection by the coronavirus. And CHMP said Regkirona should be authorized for treating adults with COVID-19 who don’t require supplemental oxygen and are also at increased risk of severe disease.

The European regulator noted the positive opinions for the COVID-19 treatments mark the first such recommendations for monoclonal antibodies, which work by attaching to the spike protein of SARS-CoV-2 and inhibit the virus from entering human cells.