Chemistry: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 | |
| Pregnancy category |
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| 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]
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". 12 May 2022. https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database.
- ↑ "AusPAR: Regdanvimab". 7 December 2021. https://www.tga.gov.au/auspar/auspar-regdanvimab.
- ↑ "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.
- ↑ 4.0 4.1 4.2 4.3 4.4 4.5 4.6 "Regkirona EPAR". 10 November 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/regkirona. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ 5.0 5.1 5.2 "Regkirona". 12 November 2021. https://ec.europa.eu/health/documents/community-register/html/h1597.htm.
- ↑ "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.
- ↑ 8.0 8.1 "EMA issues advice on use of regdanvimab for treating COVID-19". 26 March 2021. https://www.ema.europa.eu/en/news/ema-issues-advice-use-regdanvimab-treating-covid-19.
- ↑ "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.
- ↑ 11.0 11.1 "EMA receives application for marketing authorisation Regkirona (regdanvimab) treating patients with COVID-19". 4 October 2021. https://www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-regkirona-regdanvimab-treating-patients-covid-19.
- ↑ "Regkirona: Pending EC decision". 11 November 2021. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/regkirona.
- ↑ 13.0 13.1 "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.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information 35 (1). 2021. https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/rl85.pdf. Retrieved 24 April 2022.
Further reading
- "A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein". Nature Communications 12 (1): 288. January 2021. doi:10.1038/s41467-020-20602-5. PMID 33436577.
- "Regdanvimab: First Approval". Drugs 81 (18): 2133–7. December 2021. doi:10.1007/s40265-021-01626-7. PMID 34724174.
External links
- "Regdanvimab". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/regdanvimab.
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