Application for COVID-19 Treatment Submitted to EMA

The European Medicines Agency announced on October 4, 2021 that it has received an application for marketing authorization for Regkirona (regdanvimab) from Celltrion Healthcare Hungary Kft. Regkirona (regdanvimab) is a monoclonal antibody (mAb) for the treatment of COVID-19 patients who are at increased risk of developing severe COVID-19 but do not require supplemental oxygen therapy.

The agency plans to assess the risks and benefits of the mAb on a reduced timeline and, based on the robustness of the data, may have an opinion in two months because some data were already reviewed during a rolling review. A preliminary assessment of the company’s risk management plan has already been completed by EMA’s safety committee. The agency’s committee for medicines for children also issued its opinion on the company’s pediatric investigation plan.

“Should the additional data now submitted with the marketing authorisation application be sufficient for CHMP to conclude that the benefits of Regkirona outweigh its risks for the treatment of COVID 19, EMA will liaise closely with the European Commission to fast track the decision granting marketing authorisation in all EU and EEA Member States,” the agency stated in a press release.

Source: EMA