| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | Spike protein ofSARS-CoV-2 |
| Clinical data | |
| Trade names | Regkirona |
| Other names | CT-P59 |
| License data | |
| Pregnancy category | |
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
Regdanvimab, sold under the brand nameRegkirona, is ahuman monoclonal antibody used for the treatment ofCOVID-19.[4] The antibody is directed against thespike protein ofSARS-CoV-2. It is developed byCelltrion.[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]
In the European Union, regdanvimab isindicated 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, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean 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] TheEuropean 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, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean 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]
Regdanvimab is theinternational nonproprietary name (INN).[15]
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