Celltrion Gains Nod from EC for Regdanvimab

The European Commission (EC) has granted marketing authorization for Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19 who do not require supplemental oxygen and who are at an increased risk of disease progression, Celltrion Group announced on Nov. 15, 2021.

EC’s decision follows on from the positive opinion that was granted by the European Medicines Agency’s Committee for Medicinal Products for Human Health (CHMP) on Nov. 11, 2021. The approval has been based upon clinical trial data from a global Phase III study involving more than 1315 participants. In the study, it was demonstrated that regdanvimab, a monoclonal antibody therapy, significantly reduced the risk of COVID-19 related hospitalizations or death in high-risk patients.

“Today’s achievement, coupled with CHMP positive opinion for regdanvimab, underscores our ongoing commitment to addressing the world’s greatest health challenges,” said HoUng Kim, head of Medical and Marketing Division at Celltrion Healthcare, in the press release. “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. As part of our global efforts to accelerate access, we have been communicating with the governments and contractors in 30 countries in Europe, Asia, and [Latin America]. We will continue working with all key stakeholders to ensure COVID-19 patients around the world have access to safe and effective treatments.”