casirivimab/imdevimab
{{Short description|Antiviral combination medication}}
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{{Use dmy dates|date=March 2022}}
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{{Infobox drug
| type = combo
| image = File:REGN-COV2 binding SARS-CoV-2 spike protein.png
| alt =
| caption = REGN10933 (blue) and REGN10987 (orange) bound to SARS-CoV-2 spike protein (pink). From {{PDB|6VSB|6XDG}}.
| component1 = Casirivimab
| class1 = Monoclonal antibody against spike protein of SARS-CoV-2
| component2 = Imdevimab
| class2 = Monoclonal antibody against spike protein of SARS-CoV-2
| tradename = REGN-COV, Ronapreve
| Drugs.com = {{drugs.com|monograph|casirivimab-and-imdevimab}}
| MedlinePlus = a620063
| DailyMedID = Casirivimab
| pregnancy_AU = B2
| pregnancy_AU_comment = {{cite web | title=Updates to the Prescribing Medicines in Pregnancy database | website=Therapeutic Goods Administration (TGA) | date=12 May 2022 | url=https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database | access-date=13 May 2022 | archive-date=3 April 2022 | archive-url=https://web.archive.org/web/20220403064059/https://www.tga.gov.au/updates-prescribing-medicines-pregnancy-database | url-status=live }}
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| routes_of_administration = Intravenous, subcutaneous injection
| ATC_prefix = J06
| ATC_suffix = BD07
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| legal_AU = S4
| legal_AU_comment = {{cite web | title=COVID-19 treatment: Roche Products Pty Ltd, casirivimab + imdevimab (Ronapreve) | website=Therapeutic Goods Administration (TGA) | date=15 October 2021 | url=https://www.tga.gov.au/covid-19-treatment-roche-products-pty-ltd-casirivimab-imdevimab-ronapreve | access-date=22 October 2021 | archive-date=24 October 2021 | archive-url=https://web.archive.org/web/20211024103552/https://www.tga.gov.au/covid-19-treatment-roche-products-pty-ltd-casirivimab-imdevimab-ronapreve | url-status=live }}{{cite web | title=AusPAR: Casirivimab/imdevimab | website=Therapeutic Goods Administration (TGA) | date=2 November 2021 | url=https://www.tga.gov.au/auspar/auspar-casirivimabimdevimab | access-date=23 March 2022 | archive-date=21 November 2021 | archive-url=https://web.archive.org/web/20211121105334/https://www.tga.gov.au/auspar/auspar-casirivimabimdevimab | url-status=live }}
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| legal_CA = Rx-only
| legal_CA_comment = / Schedule D{{cite web | title=Casirivimab (casirivimab) and imdevimab (imdevimab) | website=Health Canada | date=9 June 2021 | url=https://covid-vaccine.canada.ca/casirivimab-and-imdevimab/product-details | access-date=20 December 2021 | archive-date=3 December 2021 | archive-url=https://web.archive.org/web/20211203063003/https://covid-vaccine.canada.ca/casirivimab-and-imdevimab/product-details | url-status=live }}{{cite web | title=Summary Basis of Decision (SBD) for Casirivimab and Imdevimab | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00537&lang=en | access-date=29 May 2022 | archive-date=29 May 2022 | archive-url=https://web.archive.org/web/20220529225637/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00537&lang=en | url-status=live }}
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| legal_UK = POM
| legal_US = Rx-Only
| legal_US_comment = via emergency use authorization
| 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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| DrugBank = DB15691
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| KEGG = D12142
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{{Infobox drug
| drug_name = Casirivimab
| type = mab
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| mab_type = mab
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| target = Spike protein of SARS-CoV-2
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| CAS_number = 2415933-42-3
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| DrugBank = DB15941
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| synonyms = REGN10933
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{{Infobox drug
| drug_name = Imdevimab
| type = mab
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| mab_type = mab
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| target = Spike protein of SARS-CoV-2
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| CAS_number = 2415933-40-1
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| DrugBank = DB15940
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| UNII = 2Z3DQD2JHM
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| KEGG = D11939
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| synonyms = REGN10987
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Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others,{{cite web | title=Casirivimab injection, solution, concentrate Imdevimab injection, solution, concentrate REGEN-COV – casirivimab and imdevimab kit | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f5bf7a31-7e17-4a94-805c-d231ea458fb0 | access-date=18 March 2021 | archive-date=4 January 2021 | archive-url=https://web.archive.org/web/20210104185039/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f5bf7a31-7e17-4a94-805c-d231ea458fb0 | url-status=live }}{{cite web | title=Ronapreve EPAR | website=European Medicines Agency | date=10 November 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ronapreve | access-date=12 November 2021 | archive-date=13 November 2021 | archive-url=https://web.archive.org/web/20211113183418/https://www.ema.europa.eu/en/medicines/human/EPAR/ronapreve | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. is a combination medicine used for the treatment and prevention of COVID{{nbhyph}}19. It consists of two human monoclonal antibodies, casirivimab and imdevimab that must be mixed together and administered as an infusion or subcutaneous injection.{{cite web | url = https://www.fda.gov/media/145611/download | date = June 2021 | format = PDF | title = Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Casirivimab And Imdevimab | website = U.S. Food and Drug Administration (FDA) | access-date = 19 March 2021 | archive-date = 2 November 2021 | archive-url = https://web.archive.org/web/20211102054324/https://www.fda.gov/media/145611/download | url-status = live }} The combination of two antibodies is intended to prevent mutational escape.{{cite journal | vauthors = Baum A, Fulton BO, Wloga E, Copin R, Pascal KE, Russo V, Giordano S, Lanza K, Negron N, Ni M, Wei Y, Atwal GS, Murphy AJ, Stahl N, Yancopoulos GD, Kyratsous CA | title = Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies | journal = Science | volume = 369 | issue = 6506 | pages = 1014–1018 | date = August 2020 | pmid = 32540904 | pmc = 7299283 | doi = 10.1126/science.abd0831 | bibcode = 2020Sci...369.1014B | doi-access=free }} It is also available as a co-formulated product. It was developed by the American biotechnology company Regeneron Pharmaceuticals.{{cite news| vauthors = Kelland K |date=14 September 2020|title=Regeneron's antibody drug added to UK Recovery trial of COVID treatments|work=Reuters|url=https://www.reuters.com/article/uk-health-coronavirus-regeneron-antibody-idUKKBN2651TR|access-date=14 September 2020|archive-date=11 January 2021|archive-url=https://web.archive.org/web/20210111003637/https://www.reuters.com/article/uk-health-coronavirus-regeneron-antibody-idUKKBN2651TR|url-status=live}}{{cite web|title=Regeneron's COVID-19 Response Efforts|url=https://www.regeneron.com/covid19|access-date=14 September 2020|website=Regeneron Pharmaceuticals|archive-date=3 December 2020|archive-url=https://web.archive.org/web/20201203042956/https://www.regeneron.com/covid19|url-status=live}}
The most common side effects include allergic reactions, which include infusion related reactions, injection site reactions, brief pain, weakness and others.{{cite web | author = Assistant Secretary for Public Affairs (ASPA) |date=7 January 2021|title=Monoclonal Antibodies for High-Risk COVID-19 Positive Patients|url=https://combatcovid.hhs.gov/possible-treatment-options-covid-19/monoclonal-antibodies-high-risk-covid-19-positive-patients|access-date=29 December 2021|website=combatCOVID.hhs.gov|archive-date=27 December 2021|archive-url=https://web.archive.org/web/20211227180325/https://combatcovid.hhs.gov/possible-treatment-options-covid-19/monoclonal-antibodies-high-risk-covid-19-positive-patients|url-status=dead}}
The combination is approved under the brand name Ronapreve for medical use in Japan, the United Kingdom, the European Union, and Australia.{{cite web | title=Ronapreve | website=Therapeutic Goods Administration (TGA) | date=18 October 2021 | url=https://www.tga.gov.au/apm-summary/ronapreve | access-date=22 October 2021 | archive-date=23 October 2021 | archive-url=https://web.archive.org/web/20211023060240/https://www.tga.gov.au/apm-summary/ronapreve | url-status=live }}{{cite web | title=Summary of Product Characteristics for Ronapreve | publisher=Medicines and Healthcare products Regulatory Agency (MHRA) | date=20 August 2021 | url=https://www.gov.uk/government/publications/regulatory-approval-of-ronapreve/summary-of-product-characteristics-for-ronapreve | access-date=29 August 2021 | archive-date=30 August 2021 | archive-url=https://web.archive.org/web/20210830040534/https://www.gov.uk/government/publications/regulatory-approval-of-ronapreve/summary-of-product-characteristics-for-ronapreve | url-status=live }}{{cite press release | title=Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19 | website=Roche | date=20 July 2021 | url=https://www.roche.com/media/releases/med-cor-2021-07-20.htm | access-date=29 August 2021 | archive-date=24 July 2021 | archive-url=https://web.archive.org/web/20210724035234/https://www.roche.com/media/releases/med-cor-2021-07-20.htm | url-status=live }}{{cite web | title=Regulatory approval of Ronapreve | publisher=Medicines and Healthcare products Regulatory Agency (MHRA) | date=20 August 2021 | url=https://www.gov.uk/government/publications/regulatory-approval-of-ronapreve | access-date=29 August 2021 | archive-date=30 August 2021 | archive-url=https://web.archive.org/web/20210830040506/https://www.gov.uk/government/publications/regulatory-approval-of-ronapreve | url-status=live }}{{cite press release | title=First monoclonal antibody treatment for COVID-19 approved for use in the UK | publisher=Medicines and Healthcare products Regulatory Agency (MHRA) | date=20 August 2021 | url=https://www.gov.uk/government/news/first-monoclonal-antibody-treatment-for-covid-19-approved-for-use-in-the-uk | access-date=29 August 2021 | archive-date=30 August 2021 | archive-url=https://web.archive.org/web/20210830040614/https://www.gov.uk/government/news/first-monoclonal-antibody-treatment-for-covid-19-approved-for-use-in-the-uk | url-status=live }}
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.{{cite press release | title=Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant | publisher=U.S. Food and Drug Administration (FDA) | date=24 January 2022 | url=https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron | access-date=24 January 2022 | archive-date=26 January 2022 | archive-url=https://web.archive.org/web/20220126234936/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron | url-status=dead }} {{PD-notice}}
Medical uses
In the European Union, the combination is indicated for the treatment of COVID{{nbhyph}}19 in people aged twelve years of age and older weighing at least {{convert|40|kg}} who do not require supplemental oxygen and who are at high increased risk of progressing to severe COVID{{nbhyph}}19; and for the prevention of COVID{{nbhyph}}19 in people aged twelve years of age and older weighing at least {{convert|40|kg}}.
Deployment
REGEN‑COV is manufactured at the Regeneron's manufacturing facility in Rensselaer, New York.{{cite news | vauthors = Williams S |title=Experimental drug given to President made locally |url=https://dailygazette.com/2020/10/03/experimental-drug-given-to-president-made-locally/ |work=The Daily Gazette |date=3 October 2020 |access-date=4 October 2020 |archive-date=1 November 2020 |archive-url=https://web.archive.org/web/20201101020753/https://dailygazette.com/2020/10/03/experimental-drug-given-to-president-made-locally/ |url-status=live }} In September 2020, to free up manufacturing capacity for REGEN‑COV, Regeneron began to shift production of its existing products from Rensselaer to the Irish city of Limerick.{{cite news | vauthors = Stanton D |title=Manufacturing shift to Ireland frees up US capacity for Regeneron's COVID antibodies |url=https://bioprocessintl.com/bioprocess-insider/facilities-capacity/manufacturing-shift-to-ireland-frees-up-us-capacity-for-regenerons-covid-antibodies/ |work=BioProcess International |date=11 September 2020 |access-date=4 October 2020 |archive-date=9 November 2020 |archive-url=https://web.archive.org/web/20201109151221/https://bioprocessintl.com/bioprocess-insider/facilities-capacity/manufacturing-shift-to-ireland-frees-up-us-capacity-for-regenerons-covid-antibodies/ |url-status=live }}
Regeneron has a deal in place with Roche (Genentech) to manufacture and market REGEN‑COV outside the United States.{{cite news|date=19 August 2020|title=Roche and Regeneron link up on a coronavirus antibody cocktail|url=https://www.cnbc.com/2020/08/19/roche-and-regeneron-link-up-on-a-coronavirus-antibody-cocktail.html|access-date=14 September 2020|website=CNBC|archive-date=13 November 2020|archive-url=https://web.archive.org/web/20201113033833/https://www.cnbc.com/2020/08/19/roche-and-regeneron-link-up-on-a-coronavirus-antibody-cocktail.html|url-status=live}}
Society and culture
On 2 October 2020, Regeneron Pharmaceuticals announced that then-US President Donald Trump had received "a single 8 gram dose of REGN-COV2" after testing positive for SARS-CoV-2.{{cite news | vauthors = Hackett DW |title=8-Gram Dose of COVID-19 Antibody Cocktail Provided to President Trump |url=https://www.precisionvaccinations.com/8-gram-dose-covid-19-antibody-cocktail-provided-president-trump |work=www.precisionvaccinations.com |date=3 October 2020 |archive-url=https://web.archive.org/web/20201003183737/https://www.precisionvaccinations.com/8-gram-dose-covid-19-antibody-cocktail-provided-president-trump |archive-date=3 October 2020 |url-status=live }} The drug was provided by the company in response to a "compassionate use" (temporary authorization for use) request from the president's physicians.{{cite news| vauthors = Thomas K |date=2 October 2020|title=President Trump Received Experimental Antibody Treatment|work=The New York Times|url=https://www.nytimes.com/2020/10/02/health/trump-antibody-treatment.html|access-date=2 October 2020|issn=0362-4331|archive-date=4 October 2020|archive-url=https://web.archive.org/web/20201004020403/https://www.nytimes.com/2020/10/02/health/trump-antibody-treatment.html|url-status=live}}
In August 2021, Texas Governor Greg Abbott received REGEN‑COV after testing positive for COVID{{nbhyph}}19.{{cite news| vauthors = Schneider A |date=17 August 2021|title=Texas Gov. Greg Abbott Tests Positive For The Coronavirus|work=NPR|url=https://www.npr.org/sections/coronavirus-live-updates/2021/08/17/1028574761/texas-governor-greg-abbott-tests-positive-covid-19-coronavirus|access-date=17 August 2021|archive-date=19 August 2021|archive-url=https://web.archive.org/web/20210819135708/https://www.npr.org/sections/coronavirus-live-updates/2021/08/17/1028574761/texas-governor-greg-abbott-tests-positive-covid-19-coronavirus|url-status=live}}
= Economics =
In January 2021, the United States agreed to purchase 1.25 million doses of the drug for $2.625 billion, at $2,100 per dose.{{cite news |title=U.S. to buy 1.25 million additional doses of Regeneron's COVID-19 antibody cocktail |url=https://www.reuters.com/article/us-health-coronavirus-usa-regeneron-phar-idUSKBN29H2ZY |access-date=30 September 2021 |work=Reuters |date=12 January 2021 |archive-date=13 October 2021 |archive-url=https://web.archive.org/web/20211013072027/https://www.reuters.com/article/us-health-coronavirus-usa-regeneron-phar-idUSKBN29H2ZY |url-status=live }}{{cite press release |date=12 January 2021 |title=Regeneron announces U.S. government agreement to purchase additional COVID-19 antibody cocktail doses |url=https://investor.regeneron.com/index.php/news-releases/news-release-details/regeneron-announces-us-government-agreement-purchase-additional |location=Tarrytown, New York |publisher=Regeneron |access-date=30 September 2021 |archive-date=8 October 2021 |archive-url=https://web.archive.org/web/20211008181750/https://investor.regeneron.com/index.php/news-releases/news-release-details/regeneron-announces-us-government-agreement-purchase-additional |url-status=live }} On 14 September, another 1.4 million doses were purchased for the same price, totaling $2.94 billion.{{cite news |title=U.S. to buy 1.4 mln additional doses of Regeneron's COVID-19 therapy |url=https://www.reuters.com/world/us/us-buy-14-mln-additional-doses-regenerons-covid-19-therapy-2021-09-14/ |access-date=30 September 2021 |work=Reuters |date=14 September 2021 |archive-date=30 September 2021 |archive-url=https://web.archive.org/web/20210930115844/https://www.reuters.com/world/us/us-buy-14-mln-additional-doses-regenerons-covid-19-therapy-2021-09-14/ |url-status=live }}
In January 2021, the German government purchased 200,000 doses for €400 million at €2,000 per dose.{{cite news |title=Coronavirus: Germany to use new antibody-based drug |url=https://www.dw.com/en/coronavirus-germany-to-use-new-antibody-based-drug/a-56328493 |access-date=30 September 2021 |work=DW |date=24 January 2021 |archive-date=8 October 2021 |archive-url=https://web.archive.org/web/20211008161454/https://www.dw.com/en/coronavirus-germany-to-use-new-antibody-based-drug/a-56328493 |url-status=live }}
In May 2021, Roche India and Cipla announced that the medicine would be available in India for Rs 59,750 (${{To USD|59750|India|year=2021}}) per dose.{{cite news |title=Roche's Antibody Cocktail launched in India at Rs 59,750/dose |url=https://indianexpress.com/article/india/roches-antibody-cocktail-launched-in-india-at-rs-59750-dose-7329310/ |access-date=30 September 2021 |work=The Indian Express |date=25 May 2021 |archive-date=30 September 2021 |archive-url=https://web.archive.org/web/20210930115915/https://indianexpress.com/article/india/roches-antibody-cocktail-launched-in-india-at-rs-59750-dose-7329310/ |url-status=live }}
In September 2021, the World Health Organization urged producers and governments to address the drug's high cost and called for technology sharing to enable the manufacture of biosimilar versions. The WHO also said that Unitaid is negotiating with Roche for lower prices and equitable distribution, especially in low- and middle income countries.{{cite news |title=On new recommendation for treatment of COVID-19 patients: WHO calls for equitable access to casirivimab and imdevimab for COVID-19 |url=https://www.who.int/news/item/24-09-2021-on-new-recommendation-for-treatment-of-covid-19-patients-who-calls-for-equitable-access-to-casirivimab-and-imdevimab-for-covid-19 |access-date=30 September 2021 |work=World Health Organization |date=24 September 2021 |archive-date=15 October 2021 |archive-url=https://web.archive.org/web/20211015151413/https://www.who.int/news/item/24-09-2021-on-new-recommendation-for-treatment-of-covid-19-patients-who-calls-for-equitable-access-to-casirivimab-and-imdevimab-for-covid-19 |url-status=live }}
= Legal status =
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 casirivimab/imdevimab (Ronapreve) for the treatment and prevention of COVID{{nbhyph}}19.{{cite web | title=Ronapreve: Pending EC decision | website=European Medicines Agency (EMA) | date=11 November 2021 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/ronapreve | access-date=11 November 2021 | archive-date=11 November 2021 | archive-url=https://web.archive.org/web/20211111195931/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/ronapreve | 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 Ronapreve is Roche Registration GmbH. Casirivimab/imdevimab was approved for medical use in the European Union in November 2021.{{cite web | title=Ronapreve Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1601.htm | access-date=3 March 2023}}
Research
= COVID-19 =
On 21 November 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate [COVID{{nbhyph}}19] in people twelve years of age or older weighing at least {{convert|40|kg|lb}} with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID{{nbhyph}}19.{{cite press release | title=Regeneron Reports Positive Interim Data with REGEN-COV Antibody Cocktail used as Passive Vaccine to Prevent COVID-19 | publisher=Regeneron Pharmaceuticals | via=PR Newswire | date=26 January 2021 | url=https://www.prnewswire.com/news-releases/regeneron-reports-positive-interim-data-with-regen-cov-antibody-cocktail-used-as-passive-vaccine-to-prevent-covid-19-301214619.html | access-date=19 March 2021 | archive-date=19 March 2021 | archive-url=https://web.archive.org/web/20210319200613/https://www.prnewswire.com/news-releases/regeneron-reports-positive-interim-data-with-regen-cov-antibody-cocktail-used-as-passive-vaccine-to-prevent-covid-19-301214619.html | url-status=live }}{{cite web| url = https://www.fda.gov/media/145610/download| date = July 2021| format = PDF| title = Casirivimab And Imdevimab Emergency Use Authorization (EUA)| website = U.S. Food and Drug Administration (FDA)| access-date = 30 July 2021| archive-date = 27 September 2021| archive-url = https://web.archive.org/web/20210927210318/https://www.fda.gov/media/145610/download| url-status = dead}} This includes those who are 65 years of age or older or who have certain chronic medical conditions. Casirivimab and imdevimab must be administered together by intravenous (IV) infusion or subcutaneous injection.
Casirivimab and imdevimab are not authorized for people who are hospitalized due to COVID{{nbhyph}}19 or require oxygen therapy due to COVID{{nbhyph}}19. A benefit of casirivimab and imdevimab treatment has not been shown in people hospitalized due to COVID{{nbhyph}}19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized people with COVID{{nbhyph}}19 requiring high flow oxygen or mechanical ventilation. In June 2021, the EUA was revised to authorize "the use of the unapproved product, REGEN‑COV (casirivimab and imdevimab) co-formulated product and REGEN‑COV (casirivimab and imdevimab) supplied as individual vials to be administered together, for the treatment of mild to moderate COVID{{nbhyph}}19 in people aged twelve years of age and older weighing at least {{convert|40|kg|lb}} with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID{{nbhyph}}19, including hospitalization or death".
The EUA was issued to Regeneron Pharmaceuticals Inc.{{cite web | title=Casirivimab and Imdevimab | website=Regeneron Pharmaceuticals | url=https://www.regeneron.com/medicines/casirivimab-imdevimab | access-date=19 March 2021 | archive-date=30 July 2021 | archive-url=https://web.archive.org/web/20210730205334/https://www.regeneron.com/medicines/casirivimab-imdevimab | url-status=live }}
In February 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started a rolling review of data on the REGN‑COV2 antibody combination (casirivimab/imdevimab), which is being co-developed by Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd (Roche) for the treatment and prevention of COVID{{nbhyph}}19.{{cite press release|date=1 February 2021|title=EMA starts rolling review of REGN‑COV2 antibody combination (casirivimab / imdevimab)|url=https://www.ema.europa.eu/en/news/ema-starts-rolling-review-regn-cov2-antibody-combination-casirivimab-imdevimab|access-date=1 February 2021|publisher=European Medicines Agency (EMA)|archive-date=15 March 2021|archive-url=https://web.archive.org/web/20210315174649/https://www.ema.europa.eu/en/news/ema-starts-rolling-review-regn-cov2-antibody-combination-casirivimab-imdevimab|url-status=live}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.{{cite press release | title=EMA reviewing data on monoclonal antibody use for COVID-19 | publisher=European Medicines Agency (EMA) | date=4 February 2021 | url=https://www.ema.europa.eu/en/news/ema-reviewing-data-monoclonal-antibody-use-covid-19 | access-date=4 March 2021 | archive-date=15 March 2021 | archive-url=https://web.archive.org/web/20210315174642/https://www.ema.europa.eu/en/news/ema-reviewing-data-monoclonal-antibody-use-covid-19 | url-status=live }} In February 2021, the CHMP concluded that the combination, also known as REGN-COV2, can be used for the treatment of confirmed COVID{{nbhyph}}19 in people who do not require supplemental oxygen and who are at high risk of progressing to severe COVID{{nbhyph}}19.{{cite press release | title=EMA issues advice on use of REGN-COV2 antibody combination (casirivimab / imdevimab) | publisher=European Medicines Agency (EMA) | date=26 February 2021 | url=https://www.ema.europa.eu/en/news/ema-issues-advice-use-regn-cov2-antibody-combination-casirivimab-imdevimab | access-date=5 March 2021 | archive-date=15 March 2021 | archive-url=https://web.archive.org/web/20210315174643/https://www.ema.europa.eu/en/news/ema-issues-advice-use-regn-cov2-antibody-combination-casirivimab-imdevimab | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
The Central Drugs Standards Control Organisation (CDSCO) in India, on 5 May 2021, granted an Emergency Use Authorization to Roche (Genentech){{cite press release | title=Genentech and Regeneron Collaborate to Significantly Increase Global Supply of REGN-COV2 Investigational Antibody Combination for COVID-19 | publisher=Genentech | via=Business Wire | date=19 August 2020 | url=https://www.businesswire.com/news/home/20200818005847/en/Genentech-and-Regeneron-Collaborate-to-Significantly-Increase-Global-Supply-of-REGN-COV2-Investigational-Antibody-Combination-for-COVID-19 | access-date=8 June 2021 | archive-date=2 June 2021 | archive-url=https://web.archive.org/web/20210602233503/https://www.businesswire.com/news/home/20200818005847/en/Genentech-and-Regeneron-Collaborate-to-Significantly-Increase-Global-Supply-of-REGN-COV2-Investigational-Antibody-Combination-for-COVID-19 | url-status=live }} and Regeneron{{cite web | title=India approves Roche/Regeneron antibody cocktail to treat Covid-19 – India News | website=The Times of India | date=5 May 2021 | url=https://timesofindia.indiatimes.com/india/india-approves-roche/regeneron-antibody-cocktail-to-treat-covid-19/articleshow/82407551.cms | access-date=8 June 2021 | archive-date=26 May 2021 | archive-url=https://web.archive.org/web/20210526230115/https://timesofindia.indiatimes.com/india/india-approves-roche/regeneron-antibody-cocktail-to-treat-covid-19/articleshow/82407551.cms | url-status=live }} for use of the casirivimab/imdevimab cocktail in the country. The announcement came in light of the second wave of the COVID{{nbhyph}}19 pandemic in India. Roche India maintains partnership with Cipla, thereby permitting the latter to market the drug in the country.{{cite web |title=Roche receives Emergency Use Authorisation in India for its investigational Antibody Cocktail (Casirivimab and Imdevimab) used in the treatment of Covid-19 |url=https://www.cipla.com/press-releases-statements/roche-receives-EUA-India-investigational-antibody-cocktail-casirivimab-Imdevimab-covid |access-date=6 May 2021 |website=Cipla |archive-date=14 June 2021 |archive-url=https://web.archive.org/web/20210614110751/https://www.cipla.com/press-releases-statements/roche-receives-EUA-India-investigational-antibody-cocktail-casirivimab-Imdevimab-covid |url-status=live }}
In July 2021, the US FDA revised the emergency use authorization (EUA) for REGEN‑COV (casirivimab and imdevimab, administered together) authorizing REGEN‑COV for emergency use as post-exposure prophylaxis (prevention) for COVID{{nbhyph}}19 in people aged twelve years of age and older weighing at least {{convert|40|kg|lb}} who are at high risk for progression to severe COVID{{nbhyph}}19, including hospitalization or death.{{cite web | title=FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19 | website=U.S. Food and Drug Administration (FDA) | date=30 July 2021 | url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19 | access-date=30 July 2021 | archive-date=30 July 2021 | archive-url=https://web.archive.org/web/20210730184115/https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19 | url-status=dead }} {{PD-notice}} REGEN‑COV remains authorized for the treatment of mild-to-moderate COVID{{nbhyph}}19 in people aged twelve years of age and older weighing at least {{convert|40|kg|lb}} with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID{{nbhyph}}19, including hospitalization or death.
In April 2021, Roche (Genentech) and Regeneron announced that the Phase III clinical trial REGN-COV 2069 met both primary and secondary endpoints, reducing risk of infection by 81% for the non-infected participants, and reducing time-to-resolution of symptoms for symptomatic participants to one week vs. three weeks in the placebo group.{{cite press release | title=Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81% | publisher=Roche | via=GlobeNewswire | date=12 April 2021 | url=https://www.globenewswire.com/news-release/2021/04/12/2207867/0/en/Phase-III-prevention-trial-showed-subcutaneous-administration-of-investigational-antibody-cocktail-casirivimab-and-imdevimab-reduced-risk-of-symptomatic-COVID-19-infections-by-81.html | access-date=1 October 2022 | archive-date=12 April 2021 | archive-url=https://web.archive.org/web/20210412215523/http://www.globenewswire.com/news-release/2021/04/12/2207867/0/en/phase-iii-prevention-trial-showed-subcutaneous-administration-of-investigational-antibody-cocktail-casirivimab-and-imdevimab-reduced-risk-of-symptomatic-covid-19-infections-by-81.html | url-status=live }}
In June 2021, preliminary results form the Recovery trial showed reduced mortality from 30% to 24% in people that had produced no antibodies themselves which were 33% of the total of participants.{{cite journal | vauthors = Kupferschmidt K |date=16 June 2021 |title=Monoclonal antibodies cut risk of dying from COVID-19 – but only in some patients |url=https://www.science.org/doi/10.1126/science.abk0053 |journal=Science |doi=10.1126/science.abk0053 |doi-broken-date=1 November 2024 |doi-access=free |access-date=6 March 2022 |archive-date=6 March 2022 |archive-url=https://web.archive.org/web/20220306141122/https://www.science.org/content/article/monoclonal-antibodies-cut-risk-dying-covid-19-only-some-patients |url-status=live }}{{cite journal | title = Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial | journal = Lancet | volume = 399 | issue = 10325 | pages = 665–676 | date = February 2022 | pmid = 35151397 | pmc = 8830904 | doi = 10.1016/S0140-6736(22)00163-5 | vauthors = Abani O, Abbas A, Abbas F, Abbas M, Abbasi S, Abbass H, Abbott A, Abdallah N, Abdelaziz A, Abdelfattah M, Abdelqader B, Abdul B, Abdul Rasheed A, Abdulakeem A, Abdul-Kadir R, Abdullah A, Abdulmumeen A, Abdul-Raheem R, Abdulshukkoor N, Abdusamad K, Abed El Khaleq Y, Abedalla M, Ul-Amna A, Abernethy K, Aboaba A, Abo-Leyah H, Abou-Haggar A, Abouibrahim M, Abraham M, Abraham T | collaboration = RECOVERY Collaborative Group }}{{cite web|title=RECOVERY trial finds Regeneron's monoclonal antibody combination reduces deaths for hospitalised COVID-19 patients who have not mounted their own immune response — RECOVERY Trial|url=https://www.recoverytrial.net/news/recovery-trial-finds-regeneron2019s-monoclonal-antibody-combination-reduces-deaths-for-hospitalised-covid-19-patients-who-have-not-mounted-their-own-immune-response-1|access-date=4 October 2021|website=www.recoverytrial.net|archive-date=4 October 2021|archive-url=https://web.archive.org/web/20211004050603/https://www.recoverytrial.net/news/recovery-trial-finds-regeneron2019s-monoclonal-antibody-combination-reduces-deaths-for-hospitalised-covid-19-patients-who-have-not-mounted-their-own-immune-response-1|url-status=live}}{{cite news|date=16 June 2021|title=Another life-saving Covid treatment found|work=BBC News|url=https://www.bbc.com/news/health-57488150|access-date=4 October 2021|archive-date=4 October 2021|archive-url=https://web.archive.org/web/20211004050558/https://www.bbc.com/news/health-57488150|url-status=live}}
In January 2024, clinical observations were published recording the full remission on long covid symptoms in 3 patients who were treated with Casirivimab/imdevimab.
= Trials =
In a clinical trial of people with COVID{{nbhyph}}19, casirivimab and imdevimab, administered together, were shown to reduce COVID{{nbhyph}}19-related hospitalization or emergency room visits in people at high risk for disease progression within 28 days after treatment when compared to placebo.{{cite press release|title=Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19|website=U.S. Food and Drug Administration (FDA)|date=21 November 2020|url=https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19|access-date=21 November 2020|archive-date=25 January 2021|archive-url=https://web.archive.org/web/20210125185046/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19|url-status=live}} {{PD-notice}} The safety and effectiveness of this investigational therapy for use in the treatment of COVID{{nbhyph}}19 continues to be evaluated.
The data supporting the emergency use authorization (EUA) for casirivimab and imdevimab are based on a randomized, double-blind, placebo-controlled clinical trial in 799 non-hospitalized adults with mild to moderate COVID{{nbhyph}}19 symptoms. Of these participants, 266 received a single intravenous infusion of 2,400 milligrams casirivimab and imdevimab (1,200 mg of each), 267 received 8,000 mg casirivimab and imdevimab (4,000 mg of each), and 266 received a placebo, within three days of obtaining a positive SARS-CoV-2 viral test.
The prespecified primary endpoint for the trial was time-weighted average change in viral load from baseline. Viral load reduction in participants treated with casirivimab and imdevimab was larger than in participants treated with placebo at day seven. However, the most important evidence that casirivimab and imdevimab administered together may be effective came from the predefined secondary endpoint of medically attended visits related to COVID{{nbhyph}}19, particularly hospitalizations and emergency room visits within 28 days after treatment. For participants at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of casirivimab and imdevimab-treated participants on average compared to 9% in placebo-treated participants. The effects on viral load, reduction in hospitalizations and ER visits were similar in participants receiving either of the two casirivimab and imdevimab doses.
As of September 2020, REGEN‑COV is being evaluated as part of the Recovery Trial,{{cite web|title=RECOVERY COVID-19 phase 3 trial to evaluate Regeneron's REGN-COV2 investigational antibody cocktail in the UK|url=https://www.recoverytrial.net/news/recovery-covid-19-phase-3-trial-to-evaluate-regeneron2019s-regn-cov2-investigational-antibody-cocktail-in-the-uk|date=14 September 2020|website=Recovery Trial|access-date=14 September 2020|archive-date=21 January 2021|archive-url=https://web.archive.org/web/20210121142018/https://www.recoverytrial.net/news/recovery-covid-19-phase-3-trial-to-evaluate-regeneron2019s-regn-cov2-investigational-antibody-cocktail-in-the-uk|url-status=live}} and in June 2021 the first results of the research were announced with evidence proving the effectiveness of the treatment.
References
{{reflist}}
Further reading
{{refbegin}}
- {{cite journal |vauthors=O'Brien MP, Forleo-Neto E, Musser BJ, Isa F, Chan KC, Sarkar N, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Hou P, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM |title=Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19 |journal=N Engl J Med |volume=385 |issue=13 |pages=1184–1195 |date=September 2021 |pmid=34347950 |pmc=8362593 |doi=10.1056/NEJMoa2109682 |doi-access=free |title-link=doi }}
{{refend}}
External links
{{commons category}}
- {{cite web | url = https://www.fda.gov/media/143891/download | format=PDF | title = Casirivimab and Imdevimab EUA Letter of Authorization | website = U.S. Food and Drug Administration (FDA) }}
- {{cite web | url = https://www.fda.gov/media/143894/download | archive-url = https://web.archive.org/web/20201122005335/https://www.fda.gov/media/143894/download | url-status = dead | archive-date = 22 November 2020 | format=PDF | title = Frequently Asked Questions on the Emergency Use Authorization of Casirivimab + Imdevimab | website = U.S. Food and Drug Administration (FDA) }}
- {{ClinicalTrialsGov|NCT04426695|Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19}}
- {{ClinicalTrialsGov|NCT04425629|Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19}}
- {{ClinicalTrialsGov|NCT04452318|COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay}}
{{Immune sera and immunoglobulins}}
{{Monoclonals for infectious disease and toxins}}
{{Portal bar | Medicine | Viruses | COVID-19}}
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Category:Combination antiviral drugs
Category:COVID-19 drug development
Category:Monoclonal antibodies