BRIEF—EC nod for Celltrion's MAb regdanvimab for COVID-19

The European Commission (EC) has approved South Korean firm Celltrion Healthcare’s Regkirona (regdanvimab, CT-P59), one of the first monoclonal antibody treatments granted marketing authorization from the European Medicines Agency.

The EC granted marketing authorization for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

The decision from the EC follows a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on November 11, 2021, which also backed Roche’s Ronapreve (casirivimab/imdevimab).

“Today’s achievement, coupled with CHMP positive opinion for regdanvimab, underscores our ongoing commitment to addressing the world’s greatest health challenges,” said Dr HoUng Kim, head of Medical and Marketing Division at Celltrion Healthcare.

“Typically, the recommendations from the CHMP are passed on to the EC for rapid legally binding decisions within a month or two, however, given the unprecedented times, we have received the EC approval within a day,” he added.