Regdanvimab
{{Short description|Monoclonal antibody}}
{{Use American English|date=March 2021}}
{{Use dmy dates|date=March 2021}}
{{Infobox drug
| drug_name =
| INN =
| type = mab
| image =
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| mab_type = mab
| source = u
| target = Spike protein of SARS-CoV-2
| pronounce =
| tradename = Regkirona
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| licence_EU = yes
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| pregnancy_AU = B2
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| routes_of_administration = Intravenous
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| ATCvet =
| ATC_prefix = J06
| ATC_suffix = BD06
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| legal_AU = S4
| legal_AU_comment = {{cite web | title=AusPAR: Regdanvimab | website=Therapeutic Goods Administration (TGA) | date=7 December 2021 | url=https://www.tga.gov.au/auspar/auspar-regdanvimab | access-date=4 January 2022 | archive-date=5 January 2022 | archive-url=https://web.archive.org/web/20220105051231/https://www.tga.gov.au/auspar/auspar-regdanvimab | url-status=live }}{{cite press release | title=TGA Provisional Approval of Celltrion Healthcare Australia Pty Ltd COVID-19 treatment, regdanvimab (Regkirona) | website=Therapeutic Goods Administration (TGA) | date=6 December 2021 | url=https://www.tga.gov.au/media-release/tga-provisional-approval-celltrion-healthcare-australia-pty-ltd-covid-19-treatment-regdanvimab-regkirona | access-date=4 January 2022 | archive-date=5 January 2022 | archive-url=https://web.archive.org/web/20220105051410/https://www.tga.gov.au/media-release/tga-provisional-approval-celltrion-healthcare-australia-pty-ltd-covid-19-treatment-regdanvimab-regkirona | url-status=live }}
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| legal_EU = Rx-only
| legal_EU_comment = {{cite web | title=COVID-19 medicines | website=European Medicines Agency (EMA) | date=14 October 2024 | url=https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines | access-date=14 October 2024}}
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| legal_status = Rx-only
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| CAS_number_Ref =
| CAS_number = 2444308-95-4
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| DrugBank_Ref =
| DrugBank = DB16405
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| UNII = I0BGE6P6I6
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| KEGG = D12241
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| synonyms = CT-P59
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Regdanvimab, sold under the brand name Regkirona, is a human monoclonal antibody used for the treatment of COVID-19.{{cite web | title=Regkirona EPAR | website=European Medicines Agency | date=10 November 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/regkirona | access-date=12 November 2021 | archive-date=12 November 2021 | archive-url=https://web.archive.org/web/20211112234216/https://www.ema.europa.eu/en/medicines/human/EPAR/regkirona | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. The antibody is directed against the spike protein of SARS-CoV-2. It is developed by Celltrion.{{cite press release | title=Celltrion Develops Tailored Neutralising Antibody Cocktail Treatment with CT-P59 to Tackle COVID-19 Variant Spread Using Its Antibody Development Platform | publisher=Celltrion | via=Business Wire | date=11 February 2021 | url=https://www.businesswire.com/news/home/20210210006036/en/Celltrion-Develops-Tailored-Neutralising-Antibody-Cocktail-Treatment-with-CT-P59-to-Tackle-COVID-19-Variant-Spread-Using-Its-Antibody-Development-Platform | access-date=4 March 2021 | archive-date=19 October 2021 | archive-url=https://web.archive.org/web/20211019085926/https://www.businesswire.com/news/home/20210210006036/en/Celltrion-Develops-Tailored-Neutralising-Antibody-Cocktail-Treatment-with-CT-P59-to-Tackle-COVID-19-Variant-Spread-Using-Its-Antibody-Development-Platform | url-status=live }}{{cite press release | title=Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59 | publisher=Celltrion | via=Business Wire | date=13 January 2021 | url=https://www.businesswire.com/news/home/20210113005355/en/Celltrion-Group-announces-positive-top-line-efficacy-and-safety-data-from-global-Phase-IIIII-clinical-trial-of-COVID-19-treatment-candidate-CT-P59 | access-date=4 March 2021 | archive-date=19 October 2021 | archive-url=https://web.archive.org/web/20211019233631/https://www.businesswire.com/news/home/20210113005355/en/Celltrion-Group-announces-positive-top-line-efficacy-and-safety-data-from-global-Phase-IIIII-clinical-trial-of-COVID-19-treatment-candidate-CT-P59 | url-status=live }} The medicine is given by infusion (drip) into a vein.{{cite web | title=EMA issues advice on use of regdanvimab for treating COVID-19 | website=European Medicines Agency | date=26 March 2021 | url=https://www.ema.europa.eu/en/news/ema-issues-advice-use-regdanvimab-treating-covid-19 | access-date=15 October 2021 | archive-date=15 November 2021 | archive-url=https://web.archive.org/web/20211115162651/https://www.ema.europa.eu/en/news/ema-issues-advice-use-regdanvimab-treating-covid-19 | url-status=live }}
The most common side effects include infusion-related reactions, including allergic reactions and anaphylaxis.
Regdanvimab was authorized for medical use in the European Union in November 2021.{{cite web | title=Regkirona | website=Union Register of medicinal products | date=12 November 2021 | url=https://ec.europa.eu/health/documents/community-register/html/h1597.htm | access-date=24 April 2022 | archive-date=24 April 2022 | archive-url=https://web.archive.org/web/20220424220714/https://ec.europa.eu/health/documents/community-register/html/h1597.htm | url-status=live }}
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.
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.{{cite press release | title=EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19 | publisher=European Medicines Agency (EMA) | date=24 February 2021 | url=https://www.ema.europa.eu/en/news/ema-starts-rolling-review-celltrion-antibody-regdanvimab-covid-19 | access-date=4 March 2021 | archive-date=15 November 2021 | archive-url=https://web.archive.org/web/20211115121425/https://www.ema.europa.eu/en/news/ema-starts-rolling-review-celltrion-antibody-regdanvimab-covid-19 | url-status=live }}{{cite press release | title=EMA review of regdanvimab for COVID-19 to support national decisions on early use | publisher=European Medicines Agency (EMA) | date=2 March 2021 | url=https://www.ema.europa.eu/en/news/ema-review-regdanvimab-covid-19-support-national-decisions-early-use | access-date=4 March 2021 | archive-date=28 October 2021 | archive-url=https://web.archive.org/web/20211028165451/https://www.ema.europa.eu/en/news/ema-review-regdanvimab-covid-19-support-national-decisions-early-use | url-status=live }} 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. The applicant is Celltrion Healthcare Hungary Kft.{{cite web | title=EMA receives application for marketing authorisation Regkirona (regdanvimab) treating patients with COVID-19 | website=European Medicines Agency | date=4 October 2021 | url=https://www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-regkirona-regdanvimab-treating-patients-covid-19 | access-date=15 October 2021 | archive-date=11 November 2021 | archive-url=https://web.archive.org/web/20211111223800/https://www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-regkirona-regdanvimab-treating-patients-covid-19 | url-status=live }} 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.
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.{{cite web | title=Regkirona: Pending EC decision | website=European Medicines Agency | date=11 November 2021 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/regkirona | access-date=11 November 2021 | archive-date=11 November 2021 | archive-url=https://web.archive.org/web/20211111160438/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/regkirona | url-status=live }}{{cite press release | title=COVID-19: EMA recommends authorisation of two monoclonal antibody medicines | website=European Medicines Agency (EMA) | date=11 November 2021 | url=https://www.ema.europa.eu/en/news/covid-19-ema-recommends-authorisation-two-monoclonal-antibody-medicines | access-date=11 November 2021 | archive-date=13 November 2021 | archive-url=https://web.archive.org/web/20211113183516/https://www.ema.europa.eu/en/news/covid-19-ema-recommends-authorisation-two-monoclonal-antibody-medicines | url-status=live }} The company that applied for authorization of Regkirona is Celltrion Healthcare Hungary Kft. Regdanvimab was authorized for medical use in the European Union in November 2021.
= Names =
Regdanvimab is the international nonproprietary name (INN).{{cite journal | vauthors = ((World Health Organization)) | year = 2021 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85 | journal = WHO Drug Information | volume = 35 | issue = 1 | url = https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/rl85.pdf | author-link = World Health Organization | access-date = 24 April 2022 | archive-date = 19 April 2021 | archive-url = https://web.archive.org/web/20210419172602/https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-%28inn%29/rl85.pdf | url-status = live }}
References
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Further reading
- {{cite journal |vauthors=Kim C, Ryu DK, Lee J, Kim YI, Seo JM, Kim YG, Jeong JH, Kim M, Kim JI, Kim P, Bae JS, Shim EY, Lee MS, Kim MS, Noh H, Park GS, Park JS, Son D, An Y, Lee JN, Kwon KS, Lee JY, Lee H, Yang JS, Kim KC, Kim SS, Woo HM, Kim JW, Park MS, Yu KM, Kim SM, Kim EH, Park SJ, Jeong ST, Yu CH, Song Y, Gu SH, Oh H, Koo BS, Hong JJ, Ryu CM, Park WB, Oh MD, Choi YK, Lee SY | display-authors=6 |title=A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein |journal=Nature Communications |volume=12 |issue=1 |pages=288 |date=January 2021 |pmid=33436577 |pmc=7803729 |doi=10.1038/s41467-020-20602-5 |doi-access=free |title-link=doi }}
- {{cite journal |vauthors=Syed YY |title=Regdanvimab: First Approval |journal=Drugs |volume=81 |issue=18 |pages=2133–7 |date=December 2021 |pmid=34724174 |pmc=8558754 |doi=10.1007/s40265-021-01626-7 | doi-access=free | title-link=doi }}
External links
- {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/regdanvimab | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Regdanvimab }}
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Category:Experimental monoclonal antibodies
Category:Experimental antiviral drugs