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Regdanvimab

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Regdanvimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetSpike protein of SARS-CoV-2
Clinical data
Trade namesRegkirona
Other namesCT-P59
License data
Pregnancy
category
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)[2][3]
  • EU: Rx-only[4][5][6]
  • In general: ℞ (Prescription only)
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.[7][8] The medicine is given by infusion (drip) into a vein.[4][9]

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

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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

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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 approved for medical use in the European Union in November 2021.[4][5]

Names

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

References

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  1. ^ "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.
  2. ^ "AusPAR: Regdanvimab". Therapeutic Goods Administration (TGA). 7 December 2021. Archived from the original on 5 January 2022. Retrieved 4 January 2022.
  3. ^ "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. ^ a b c d e f g "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.
  5. ^ a b c "Regkirona". Union Register of medicinal products. 12 November 2021. Archived from the original on 24 April 2022. Retrieved 24 April 2022.
  6. ^ "COVID-19 medicines". European Medicines Agency (EMA). 14 October 2024. Retrieved 14 October 2024.
  7. ^ "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.
  8. ^ "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.
  9. ^ a b "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.
  10. ^ "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.
  11. ^ "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.
  12. ^ a b "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.
  13. ^ "Regkirona: Pending EC decision". European Medicines Agency. 11 November 2021. Archived from the original on 11 November 2021. Retrieved 11 November 2021.
  14. ^ a b "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.
  15. ^ 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

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  • "Regdanvimab". Drug Information Portal. U.S. National Library of Medicine.
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