Monoclonal antibody | |
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Type | Whole antibody |
Source | Human |
Target | Spike protein of SARS-CoV-2 |
Clinical data | |
Trade names | Regkirona |
Other names | CT-P59 |
License data | |
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Routes of administration | Intravenous |
ATC code | |
Legal status | |
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DrugBank | |
UNII | |
KEGG |
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.[6][7] The medicine is given by infusion (drip) into a vein.[4][8]
The most common side effects include infusion-related reactions, including allergic reactions and anaphylaxis.[4]
Regdanvimab was approved for medical use in the European Union in November 2021.[4][5]
In 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]
In 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.[9][10] 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.[11] The applicant is Celltrion Healthcare Hungary Kft.[11] 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.[8]
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.[12][13] The company that applied for authorization of Regkirona is Celltrion Healthcare Hungary Kft.[13] Regdanvimab was approved for medical use in the European Union in November 2021.[4][5]
Regdanvimab is the international nonproprietary name (INN).[14]