EMA starts reviewing Regkirona for COVID-19 patients
The European Medicines Agency today said it has started evaluating an application for marketing authorization for the monoclonal antibody Regkirona (regdanvimab, also known as CT-P59) to treat adults with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID‑19.
The applicant is Celltrion Healthcare Hungary, a part of South Korea’s Celltrion Healthcare (Kosdaq: 068270).
The EMA will assess the benefits and risks of Regkirona under a reduced timeline and could issue an opinion within two months, depending on the robustness of the data submitted and whether further information is required to support the evaluation.
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