Regdanvimab
Regdanvimab, sold under the brand name Regkirona, is a human monoclonal antibody used for the treatment of COVID-19.[4] The antibody is directed against the spike protein of SARS-CoV-2. It is developed by Celltrion.[7][8] The medicine is given by infusion (drip) into a vein.[4][9] The most common side effects include infusion-related reactions, including allergic reactions and anaphylaxis.[4] Regdanvimab was authorized for medical use in the European Union in November 2021.[4][5] Medical usesIn the European Union, regdanvimab is indicated for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.[4] Society and cultureLegal statusIn March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started a rolling review of data on regdanvimab.[10][11] In October 2021, the EMA started evaluating an application for marketing authorization for the monoclonal antibody regdanvimab (Regkirona) 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.[12] The applicant is Celltrion Healthcare Hungary Kft.[12] The European Medicines Agency (EMA) concluded that regdanvimab can be used for the treatment of confirmed COVID-19 in adults who do not require supplemental oxygen therapy and who are at high risk of progressing to severe COVID-19.[9] In November 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting a marketing authorization in the European Union for regdanvimab (Regkirona) for the treatment of COVID-19.[13][14] The company that applied for authorization of Regkirona is Celltrion Healthcare Hungary Kft.[14] Regdanvimab was authorized for medical use in the European Union in November 2021.[4][5] NamesRegdanvimab is the international nonproprietary name (INN).[15] References
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