Monoclonal antibody | |
---|---|
Type | Whole antibody |
Source | Human |
Target | Spike protein of SARS-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 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]
Monoclonal antibody | |
---|---|
Type | Whole antibody |
Source | Human |
Target | Spike protein of SARS-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 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]