EC approves Celltrion’s COVID-19 mAb Regkirona

The European Commission (EC) has authorised Celltrion’s COVID-19 monoclonal antibody (mAb) treatment Regkirona (regdanvimab, CT-P59), the company announced yesterday.

The marketing authorisation allows for the use of Regkirona for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at an increased risk of progression to severe disease.

This approval is based on Celltrion’s Phase III trial, which evaluated the safety and efficacy of Regkirona among COVID-19 patients. According to data from this trial, Regkirona significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high-risk of progressing to severe COVID-19.

“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. 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 LATAM. We will continue working with all key stakeholders to ensure COVID-19 patients around the world have access to safe and effective treatments,” he added.