EMA Endorses COVID-19 Antibody Therapies From Regeneron-Roche, Celltrion

November 12, 2021

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) yesterday.

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.

Ronapreve’s recommendation was supported by positive data from two-late stage studies, enrolling more than 6,000 people, with one trial assessing the treatment’s ability to reduce hospitalization and death and the other evaluating the therapy’s success at preventing COVID-19 infection among household members.

Meanwhile, CHMP supported Regkirona based on a study showing the drug cut down patient hospitalization and death as well as the need for supplemental oxygen vs. placebo. The late-stage trial enrolled 446 patients in the experimental arm and 434 in the placebo cohort.

The news arrived in what has been a big week for Regeneron. Days earlier, the company announced casirivimab and imdevimab slashed the risk of contracting COVID-19 infection by 81.6 percent up to eight months following treatment in a phase 3 trial (DID, Nov. 9). ― Jason Scott