Tixagevimab/cilgavimab explained

Type:combo
Component1:Tixagevimab
Class1:Monoclonal antibody
Component2:Cilgavimab
Class2:Monoclonal antibody
Tradename:Evusheld
Dailymedid:Tixagevimab
Pregnancy Au:B2
Pregnancy Au Comment:[1] [2] [3]
Routes Of Administration:Intramuscular
Atc Prefix:J06B
Atc Suffix:D03
Legal Au:S4
Legal Au Comment:[4] [5] [6]
Legal Ca:Rx-only
Legal Ca Comment:/ Schedule D[7] [8] [9]
Legal Uk:POM
Legal Uk Comment:[10] [11]
Legal Eu:Rx-Only
Legal Eu Comment:[12] [13]
Kegg:D12262
Synonyms:AZD7442
Drug Name:Tixagevimab
Class:Antiviral
Atc Prefix:None
Cas Number:2420564-02-7
Drugbank:DB16394
Unii:F0LZ415Z3B
Kegg:D11993
C:6488
H:10034
N:1746
O:2038
S:50
Drug Name:Cilgavimab
Class:Antiviral
Atc Prefix:None
Cas Number:2420563-99-9
Drugbank:DB16393
Unii:1KUR4BN70F
Kegg:D11994
C:6626
H:10218
N:1750
O:2078
S:44

Tixagevimab/cilgavimab, sold under the brand name Evusheld, is a combination of two human monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061) targeted against the surface spike protein of SARS-CoV-2[14] [15] used to prevent COVID-19.[16] It is being developed by British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca.[17] [18] It is co-packaged and given as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession).[19]

Development

In 2020, researchers at Vanderbilt University Medical Center discovered particularly potent monoclonal antibodies, isolated from COVID-19 patients infected with a SARS-CoV-2 circulating at that time. Initially designated COV2-2196 and COV2-2130, antibody engineering was used to transfer their SARS-CoV-2 binding specificity to IgG scaffolds that would last longer in the body, and these engineered antibodies were named AZD8895 (tixagevimab) and AZD1061 (cilgavimab), respectively (and the combination was called AZD7442).

To evaluate the potential of the antibodies as monoclonal antibody based prophylaxis (prevention), the 'Provent' clinical trial enrolled 5,000 high risk but not yet infected individuals and monitored them for 15 months.[20] The trial reported that those receiving the cocktail showed a 77% reduction in symptomatic COVID-19 and that there were no severe cases or deaths. AstraZeneca also found that the antibody cocktail "neutralizes recent emergent SARS-CoV-2 viral variants" including the Delta variant, and the Omicron variant.[21]

In contrast to pre-exposure prophylaxis, the Storm Chaser study of already-exposed people (post-exposure prophylaxis) did not meet its primary endpoint, which was prevention of symptomatic COVID-19 in people already exposed. AZD7442 was administered to 1,000 volunteers who had recently been exposed to COVID.[22]

Society and culture

Legal status

In October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started a rolling review of tixagevimab/cilgavimab, which is being developed by AstraZeneca AB, for the prevention of COVID-19 in adults.[23] It was approved for medical use in the European Union in March 2022.

Also in October 2021, AstraZeneca requested emergency use authorization for tixagevimab/cilgavimab to prevent COVID-19 from the US Food and Drug Administration (FDA).[24]

In November 2021, Bahrain authorized it for emergency use.[25]

In December 2021, the US FDA granted emergency use authorization (EUA) of this combination to prevent COVID-19 (before exposure) in people with weakened immunity or who cannot be fully vaccinated due to a history of severe reaction to coronavirus vaccines. and in certain people aged 12 years of age and older weighing at least 40kg (90lb). The product is only authorized for those individuals who are not infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2.[26] The EUA was revoked in January 2023.

In March 2022, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Evusheld, intended for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40kg (90lb). The applicant for this medicinal product is AstraZeneca AB.[27] It has since been granted approval for use in the UK[28] [29] and in the European Union.[30]

In January 2023, the FDA revised the EUA for Evusheld to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision, Evusheld is not authorized for use in the US.[31]

External links

Notes and References

  1. Web site: Evusheld APMDS . Therapeutic Goods Administration (TGA) . 7 March 2022 . 23 March 2022 . 24 March 2022 . https://web.archive.org/web/20220324041927/https://www.tga.gov.au/apm-summary/evusheld . live .
  2. Web site: Updates to the Prescribing Medicines in Pregnancy database . Therapeutic Goods Administration (TGA) . 21 December 2022 . 2 January 2023 . 3 April 2022 . https://web.archive.org/web/20220403064059/https://www.tga.gov.au/updates-prescribing-medicines-pregnancy-database . live .
  3. Web site: Evusheld APMDS . Therapeutic Goods Administration (TGA) . 21 December 2022 . 4 January 2023 . 5 January 2023 . https://web.archive.org/web/20230105011604/https://www.tga.gov.au/resources/auspmd/evusheld-0 . live .
  4. Web site: Evusheld . Therapeutic Goods Administration (TGA) . 23 March 2022 . 24 March 2022 . https://web.archive.org/web/20220324041823/https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=378245 . dead .
  5. Web site: AusPAR: Tixagevimab and cilgavimab . Therapeutic Goods Administration (TGA) . 11 March 2022 . 23 March 2022 . 24 March 2022 . https://web.archive.org/web/20220324042018/https://www.tga.gov.au/auspar/auspar-tixagevimab-and-cilgavimab . live .
  6. https://www.tga.gov.au/resources/artg/378245 Archived copy
  7. Web site: Evusheld Product information . . 25 April 2012 . 29 May 2022 . 29 May 2022 . https://web.archive.org/web/20220529065732/https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=101539 . live .
  8. Web site: Evusheld . . 14 April 2022 . 31 May 2022 . 14 April 2022 . https://web.archive.org/web/20220414142938/https://covid-vaccine.canada.ca/evusheld/product-details . live .
  9. Web site: Summary Basis of Decision – Evusheld . Health Canada . 23 October 2014 . 6 August 2022 . 6 August 2022 . https://web.archive.org/web/20220806062653/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00589&lang=en . live .
  10. Web site: Regulatory approval of Evusheld (tixagevimab/cilgavimab) . Medicines & Healthcare products Regulatory Agency . 17 March 2022 . 10 June 2022 . 10 June 2022 . https://web.archive.org/web/20220610203810/https://www.gov.uk/government/publications/regulatory-approval-of-evusheld-tixagevimabcilgavimab . live .
  11. Web site: Summary of Product Characteristics for Evusheld . Medicines & Healthcare products Regulatory Agency . 17 March 2022 . 10 June 2022 . 10 June 2022 . https://web.archive.org/web/20220610203826/https://www.gov.uk/government/publications/regulatory-approval-of-evusheld-tixagevimabcilgavimab/summary-of-product-characteristics-for-evusheld . live .
  12. Web site: Evusheld EPAR . European Medicines Agency (EMA) . 22 March 2022 . 24 April 2022 . 16 April 2022 . https://web.archive.org/web/20220416072326/https://www.ema.europa.eu/en/medicines/human/EPAR/evusheld . live .
  13. Web site: Evusheld . Union Register of medicinal products . 25 March 2022 . 24 April 2022 . 28 March 2022 . https://web.archive.org/web/20220328103329/https://ec.europa.eu/health/documents/community-register/html/h1651.htm . live .
  14. Web site: 27 December 2021 . Cilgavimab . IUPHAR/BPS Guide to Pharmacology . 27 December 2021 . . 27 December 2021 . https://web.archive.org/web/20211227065035/https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=11329 . live .
  15. Web site: 27 December 2021 . Tixagevimab . IUPHAR/BPS Guide to Pharmacology . 27 December 2021 . . 27 December 2021 . https://web.archive.org/web/20211227065042/https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=11330 . live .
  16. Abramowicz M, Zuccotti G, Pflomm JM . Tixagevimab and Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis of COVID-19 . JAMA . 327 . 4 . 384–385 . January 2022 . 35076671 . 10.1001/jama.2021.24931 . doi . free .
  17. News: Ray S . 21 August 2021 . AstraZeneca's Covid-19 Antibody Therapy Effective In Preventing Symptoms Among High-Risk Groups, Trial Finds . live . limited . https://archive.today/20210821001109/https://www.forbes.com/sites/carlieporterfield/2021/08/20/kylie-jenner-reportedly-pregnant-with-second-child/?sh=477d34cf32b7 . 21 August 2021 . 18 January 2022. . 0015-6914 .
  18. Web site: Goriainoff AO . 20 August 2021 . AstraZeneca Says AZD7442 Antibody Phase 3 Trial Met Primary Endpoint in Preventing Covid-19 . live . https://archive.today/20210821152128/https://www.marketwatch.com/story/astrazeneca-says-azd7442-antibody-phase-3-trial-met-primary-endpoint-in-preventing-covid-19-271629440744 . 21 August 2021 . 18 January 2022 . . limited .
  19. Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals . U.S. Food and Drug Administration (FDA) . 8 December 2021 . 9 December 2021 . 28 April 2022 . https://web.archive.org/web/20220428174550/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure . live .
  20. AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in preventing COVID-19 . AstraZeneca . 20 August 2021 . 15 October 2021 . 19 November 2021 . https://web.archive.org/web/20211119080903/https://www.astrazeneca-us.com/media/press-releases/2021/azd7442-provent-phase-iii-prophylaxis-trial-met-primary-endpoint-in-preventing-covid-19-08202021.html . live .
  21. News: 21 March 2022 . AstraZeneca COVID drug neutralises Omicron sub-variants in lab study . Reuters . 5 April 2022 . 22 April 2022 . https://web.archive.org/web/20220422183858/https://www.reuters.com/business/healthcare-pharmaceuticals/astrazeneca-antibody-cocktail-retains-activity-against-omicron-subvariants-2022-03-21/ . live .
  22. Web site: Haridy R. 23 August 2021. "Game-changing" antibody cocktail prevents COVID-19 in the chronically ill. 23 August 2021. New Atlas. 10 October 2021. https://web.archive.org/web/20211010101618/https://newatlas.com/health-wellbeing/astrazeneca-antibody-coronavirus-phase3-trial-results/. live.
  23. Web site: EMA starts rolling review of Evusheld (tixagevimab and cilgavimab) . European Medicines Agency (EMA) . 14 October 2021 . 15 October 2021 . 8 November 2021 . https://web.archive.org/web/20211108171936/https://www.ema.europa.eu/en/news/ema-starts-rolling-review-evusheld-tixagevimab-cilgavimab . live .
  24. AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US . AstraZeneca . 5 October 2021 . 15 October 2021 . 15 October 2021 . https://web.archive.org/web/20211015211200/https://www.astrazeneca-us.com/media/press-releases/2021/azd7442-request-for-emergency-use-authorization-for-covid-19-prophylaxis-filed-in-us-10052021.html . live .
  25. News: Abd-Alaziz M, Elhamy A . Macfie N . Bahrain authorizes AstraZeneca's anti-COVID drug for emergency use . . 18 January 2022 . 14 November 2021 . https://web.archive.org/web/20211123052530/https://www.reuters.com/business/healthcare-pharmaceuticals/bahrain-authorizes-astrazenecas-anti-covid-drug-emergency-use-2021-11-14/ . 23 November 2021 . live . limited .
  26. Web site: FDA authorizes revisions to Evusheld dosing . U.S. Food and Drug Administration (FDA) . 24 February 2022 . 27 February 2022 . 27 February 2022 . https://web.archive.org/web/20220227043716/https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-revisions-evusheld-dosing . live .
  27. Web site: Evusheld: Pending EC decision . European Medicines Agency (EMA) . 25 March 2022 . 25 March 2022 . 25 March 2022 . https://web.archive.org/web/20220325132347/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/evusheld . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  28. News: 17 March 2022 . AstraZeneca's Evusheld Covid-prevention drug gets UK approval . 5 April 2022 . . 25 April 2022 . https://web.archive.org/web/20220425000255/https://www.theguardian.com/business/2022/mar/17/astrazenecas-evusheld-covid-prevention-drug-gets-uk-approval . live .
  29. News: Fourcade M . Astra Covid Antibody Gets U.K. Approval for People With Poor Immunity . 5 April 2022 . Bloomberg . 6 April 2022 . https://web.archive.org/web/20220406093312/https://www.bloomberg.com/news/articles/2022-03-17/astra-covid-antibody-gets-u-k-nod-for-people-with-poor-immunity . live .
  30. News: New drug that prevents you from catching COVID-19 given green light in Europe . 5 April 2022 . Fortune . 25 April 2022 . https://web.archive.org/web/20220425025146/https://fortune.com/2022/03/29/astrazeneca-evusheld-covid-19-prevention-drug-given-green-light-europe/ . live .
  31. Web site: Latest FDA Updates for Evusheld . U.S. Food and Drug Administration . 26 January 2023 . 26 January 2023 . 14 March 2023 . https://web.archive.org/web/20230314042605/https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-evusheld-not-currently-authorized-emergency-use-us . live .

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