Regdanvimab

Regdanvimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetSpike protein of SARS-CoV-2
Clinical data
Trade namesRegkirona
Other namesCT-P59
License data
Routes of
administration		Intravenous infusion
ATC code
  • None
Legal status
Legal status
  • AU: S4 (Prescription only) [1][2]
  • EU: Rx-only [3]
  • 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.[3] The antibody is directed against the spike protein of SARS-CoV-2. It is developed by Celltrion.[4][5] The medicine is given by infusion (drip) into a vein.[3][6]

The most common side effects include infusion-related reactions, including allergic reactions and anaphylaxis.[3]

Regdanvimab was approved for medical use in the European Union in November 2021.[3]

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.[3]

Society and culture

Names

Regdanvimab is the proposed international nonproprietary name (pINN).[7]

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.[8][9] 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.[10] The applicant is Celltrion Healthcare Hungary Kft.[10] 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.[6]

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.[11][12] The company that applied for authorization of Regkirona is Celltrion Healthcare Hungary Kft.[12] Regdanvimab was approved for medical use in the European Union in November 2021.[3]

References

  1. ↑ "AusPAR: Regdanvimab". Therapeutic Goods Administration (TGA). 7 December 2021. Retrieved 4 January 2022.
  2. ↑ "TGA Provisional Approval of Celltrion Healthcare Australia Pty Ltd COVID-19 treatment, regdanvimab (Regkirona)". Therapeutic Goods Administration (TGA) (Press release). 6 December 2021. Retrieved 4 January 2022.
  3. 1 2 3 4 5 6 7 "Regkirona EPAR". European Medicines Agency. Retrieved 12 November 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. ↑ "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. Retrieved 4 March 2021 – via Business Wire.
  5. ↑ "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. Retrieved 4 March 2021 – via Business Wire.
  6. 1 2 "EMA issues advice on use of regdanvimab for treating COVID-19". European Medicines Agency. 26 March 2021. Retrieved 15 October 2021.
  7. ↑ World Health Organization (2020). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 124 – COVID-19 (special edition)" (PDF). WHO Drug Information. 34 (3): 660–1.
  8. ↑ "EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19" (Press release). European Medicines Agency (EMA). 24 February 2021. Retrieved 4 March 2021.
  9. ↑ "EMA review of regdanvimab for COVID-19 to support national decisions on early use" (Press release). European Medicines Agency (EMA). 2 March 2021. Retrieved 4 March 2021.
  10. 1 2 "EMA receives application for marketing authorisation Regkirona (regdanvimab) treating patients with COVID-19". European Medicines Agency. 4 October 2021. Retrieved 15 October 2021.
  11. ↑ "Regkirona: Pending EC decision". European Medicines Agency. 11 November 2021. Retrieved 11 November 2021.
  12. 1 2 "COVID-19: EMA recommends authorisation of two monoclonal antibody medicines". European Medicines Agency (EMA) (Press release). 11 November 2021. Retrieved 11 November 2021.

Further reading

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


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