Regdanvimab
Monoclonal antibody
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 | |
Pregnancy
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administration |
Intravenous |
ATC code | |
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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]
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. [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]
Names
Regdanvimab is the international nonproprietary name (INN). [14]
References
- ↑ "Updates to the Prescribing Medicines in Pregnancy database" . Therapeutic Goods Administration (TGA) . 12 May 2022. Archived from the original on 3 April 2022 . Retrieved 13 May 2022 .
- ↑ "AusPAR: Regdanvimab" . Therapeutic Goods Administration (TGA) . 7 December 2021. Archived from the original on 5 January 2022 . Retrieved 4 January 2022 .
- ↑ "TGA Provisional Approval of Celltrion Healthcare Australia Pty Ltd COVID-19 treatment, regdanvimab (Regkirona)" . Therapeutic Goods Administration (TGA) (Press release). 6 December 2021. Archived from the original on 5 January 2022 . Retrieved 4 January 2022 .
- 1 2 3 4 5 6 7 "Regkirona EPAR" . European Medicines Agency . 10 November 2021. Archived from the original on 12 November 2021 . Retrieved 12 November 2021 . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- 1 2 3 "Regkirona" . Union Register of medicinal products . 12 November 2021. Archived from the original on 24 April 2022 . Retrieved 24 April 2022 .
- ↑ "Celltrion Develops Tailored Neutralising Antibody Cocktail Treatment with CT-P59 to Tackle COVID-19 Variant Spread Using Its Antibody Development Platform" (Press release). Celltrion. 11 February 2021. Archived from the original on 19 October 2021 . Retrieved 4 March 2021 – via Business Wire.
- ↑ "Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59" (Press release). Celltrion. 13 January 2021. Archived from the original on 19 October 2021 . Retrieved 4 March 2021 – via Business Wire.
- 1 2 "EMA issues advice on use of regdanvimab for treating COVID-19" . European Medicines Agency . 26 March 2021. Archived from the original on 15 November 2021 . Retrieved 15 October 2021 .
- ↑ "EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19" (Press release). European Medicines Agency (EMA). 24 February 2021. Archived from the original on 15 November 2021 . Retrieved 4 March 2021 .
- ↑ "EMA review of regdanvimab for COVID-19 to support national decisions on early use" (Press release). European Medicines Agency (EMA). 2 March 2021. Archived from the original on 28 October 2021 . Retrieved 4 March 2021 .
- 1 2 "EMA receives application for marketing authorisation Regkirona (regdanvimab) treating patients with COVID-19" . European Medicines Agency . 4 October 2021. Archived from the original on 11 November 2021 . Retrieved 15 October 2021 .
- ↑ "Regkirona: Pending EC decision" . European Medicines Agency . 11 November 2021. Archived from the original on 11 November 2021 . Retrieved 11 November 2021 .
- 1 2 "COVID-19: EMA recommends authorisation of two monoclonal antibody medicines" . European Medicines Agency (EMA) (Press release). 11 November 2021. Archived from the original on 13 November 2021 . Retrieved 11 November 2021 .
- ↑ World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85" (PDF) . WHO Drug Information . 35 (1). Archived (PDF) from the original on 19 April 2021 . Retrieved 24 April 2022 .
Further reading
- Kim C, Ryu DK, Lee J, Kim YI, Seo JM, Kim YG, et al. (January 2021). "A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein" . Nature Communications . 12 (1): 288. doi : 10.1038/s41467-020-20602-5 . PMC 7803729 . PMID 33436577 .
- Syed YY (December 2021). "Regdanvimab: First Approval" . Drugs . 81 (18): 2133–7. doi : 10.1007/s40265-021-01626-7 . PMC 8558754 . PMID 34724174 .
External links
- "Regdanvimab" . Drug Information Portal . U.S. National Library of Medicine.
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