Casirivimab/imdevimab

Casirivimab/imdevimab
REGN10933 (blue) and REGN10987 (orange) bound to SARS-CoV-2 spike protein (pink). From PDB: 6VSB, 6XDG​.
Combination of
CasirivimabMonoclonal antibody against spike protein of SARS-CoV-2
ImdevimabMonoclonal antibody against spike protein of SARS-CoV-2
Clinical data
Trade namesREGEN-COV, Ronapreve
AHFS/Drugs.comMonograph
MedlinePlusa620063
License data
Pregnancy
category
Routes of
administration		Intravenous, subcutaneous injection
ATC code
Legal status
Legal status
Identifiers
DrugBank
KEGG
Casirivimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetSpike protein of SARS-CoV-2
Clinical data
Other namesREGN10933
ATC code
  • None
Identifiers
CAS Number
DrugBank
UNII
KEGG
Imdevimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetSpike protein of SARS-CoV-2
Clinical data
Other namesREGN10987
ATC code
  • None
Identifiers
CAS Number
DrugBank
UNII
KEGG

Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others,[8][10] is a combination medicine used for the treatment and prevention of COVID‑19.[10] It consists of two human monoclonal antibodies, casirivimab and imdevimab that must be mixed together and administered as an infusion or subcutaneous injection.[13][8][10] The combination of two antibodies is intended to prevent mutational escape.[14] It is also available as a co-formulated product.[13] It was developed by the American biotechnology company Regeneron Pharmaceuticals.[15][16]

The most common side effects include allergic reactions, which include infusion related reactions, injection site reactions,[10] brief pain, weakness and others.[17]

The combination is approved under the brand name Ronapreve for medical use in Japan, the United Kingdom, the European Union, and Australia.[1][7][10][12][18][19]

In January 2022, the U.S. Food and Drug Administration (FDA) revised the authorizations for two monoclonal antibody treatments – bamlanivimab/etesevimab (administered together) and casirivimab/imdevimab – to limit their use to only when the recipients are likely to have been infected with or exposed to a variant that is susceptible to these treatments because data show these treatments are highly unlikely to be active against the omicron variant.[20]

  1. ^ a b c "Ronapreve". Therapeutic Goods Administration (TGA). 18 October 2021. Archived from the original on 23 October 2021. Retrieved 22 October 2021.
  2. ^ a b "AusPAR: Casirivimab/imdevimab". Therapeutic Goods Administration (TGA). 2 November 2021. Archived from the original on 21 November 2021. Retrieved 23 March 2022.
  3. ^ "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.
  4. ^ "COVID-19 treatment: Roche Products Pty Ltd, casirivimab + imdevimab (Ronapreve)". Therapeutic Goods Administration (TGA). 15 October 2021. Archived from the original on 24 October 2021. Retrieved 22 October 2021.
  5. ^ "Casirivimab (casirivimab) and imdevimab (imdevimab)". Health Canada. 9 June 2021. Archived from the original on 3 December 2021. Retrieved 20 December 2021.
  6. ^ "Summary Basis of Decision (SBD) for Casirivimab and Imdevimab". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  7. ^ a b "Summary of Product Characteristics for Ronapreve". Medicines and Healthcare products Regulatory Agency (MHRA). 20 August 2021. Archived from the original on 30 August 2021. Retrieved 29 August 2021.
  8. ^ a b c "Casirivimab injection, solution, concentrate Imdevimab injection, solution, concentrate REGEN-COV – casirivimab and imdevimab kit". DailyMed. Archived from the original on 4 January 2021. Retrieved 18 March 2021.
  9. ^ Cite error: The named reference FDA PR 20201121 was invoked but never defined (see the help page).
  10. ^ a b c d e f "Ronapreve EPAR". European Medicines Agency. 10 November 2021. Archived from the original on 13 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.
  11. ^ "COVID-19 medicines". European Medicines Agency (EMA). 14 October 2024. Retrieved 14 October 2024.
  12. ^ a b "Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19". Roche (Press release). 20 July 2021. Archived from the original on 24 July 2021. Retrieved 29 August 2021.
  13. ^ a b "Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Casirivimab And Imdevimab" (PDF). U.S. Food and Drug Administration (FDA). June 2021. Archived from the original on 2 November 2021. Retrieved 19 March 2021.
  14. ^ Baum A, Fulton BO, Wloga E, Copin R, Pascal KE, Russo V, et al. (August 2020). "Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies". Science. 369 (6506): 1014–1018. Bibcode:2020Sci...369.1014B. doi:10.1126/science.abd0831. PMC 7299283. PMID 32540904.
  15. ^ Kelland K (14 September 2020). "Regeneron's antibody drug added to UK Recovery trial of COVID treatments". Reuters. Archived from the original on 11 January 2021. Retrieved 14 September 2020.
  16. ^ "Regeneron's COVID-19 Response Efforts". Regeneron Pharmaceuticals. Archived from the original on 3 December 2020. Retrieved 14 September 2020.
  17. ^ Assistant Secretary for Public Affairs (ASPA) (7 January 2021). "Monoclonal Antibodies for High-Risk COVID-19 Positive Patients". combatCOVID.hhs.gov. Archived from the original on 27 December 2021. Retrieved 29 December 2021.
  18. ^ "Regulatory approval of Ronapreve". Medicines and Healthcare products Regulatory Agency (MHRA). 20 August 2021. Archived from the original on 30 August 2021. Retrieved 29 August 2021.
  19. ^ "First monoclonal antibody treatment for COVID-19 approved for use in the UK" (Press release). Medicines and Healthcare products Regulatory Agency (MHRA). 20 August 2021. Archived from the original on 30 August 2021. Retrieved 29 August 2021.
  20. ^ "Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant" (Press release). U.S. Food and Drug Administration (FDA). 24 January 2022. Archived from the original on 26 January 2022. Retrieved 24 January 2022. Public Domain This article incorporates text from this source, which is in the public domain.