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]

Regdanvimab

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	EU EMA: by INN
Pregnancy category	AU: B2[1]
Routes of administration	Intravenous
ATC code	J06BD06 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)[2][3] EU: Rx-only[4][5][6] In general: ℞ (Prescription only)
Identifiers
CAS Number	2444308-95-4
DrugBank	DB16405
UNII	I0BGE6P6I6
KEGG	D12241

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 uses

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]

Society and culture

Legal status

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.^[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]

Names

Regdanvimab is the international nonproprietary name (INN).^[15]