pemivibart

{{Infobox drug

| type = mab

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| mab_type = mab

| source = u

| target = Spike protein of SARS-CoV-2

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| tradename = Pemgarda

| Drugs.com = {{drugs.com|monograph|pemivibart}}

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| DailyMedID = Pemivibart

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| routes_of_administration = Intravenous

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| legal_US = Rx-only

| legal_US_comment = via EUA{{cite web | title=Pemgarda- pemivibart injection | website=DailyMed | date=22 March 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0bdc20a9-791f-9a06-e063-6394a90a84cc | access-date=17 October 2024}}{{cite web | title = Emergency Use Authorization: Pemgarda (pemivibart) | date = 22 March 2024 | publisher = U.S. Food and Drug Administration (FDA) | url = https://www.fda.gov/media/177068/download| archive-url = https://web.archive.org/web/20240323205755/https://www.fda.gov/media/177068/download| url-status = dead| archive-date = 23 March 2024}}

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| CAS_number = 2858673-18-2

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| IUPHAR_ligand =

| DrugBank = DB18720

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| UNII = 557S3L3FAP

| KEGG = D12876

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| PDB_ligand =

| synonyms = VYD222

}}

Pemivibart, sold under the brand name Pemgarda, is a monoclonal antibody medication authorized for the pre-exposure prophylaxis (prevention) of COVID{{nbhyph}}19. Pemivibart was developed by Invivyd.{{cite web |url=https://www.fda.gov/media/177067/download |title= Highlight of Emergency Use Authorization: Pemgarda (pemivibart) | publisher = U.S. Food and Drug Administration (FDA) |access-date=23 March 2024 |archive-date=23 March 2024 |archive-url=https://web.archive.org/web/20240323211217/https://www.fda.gov/media/177067/download |url-status=dead }}

The US Food and Drug Administration (FDA) issued an emergency use authorization for pemivibart in March 2024.{{cite web | title=FDA Roundup: March 22, 2024 | website=U.S. Food and Drug Administration (FDA) | date=22 March 2024 | url=https://www.fda.gov/news-events/press-announcements/fda-roundup-march-22-2024 | access-date=23 March 2024 | archive-date=23 March 2024 | archive-url=https://web.archive.org/web/20240323211210/https://www.fda.gov/news-events/press-announcements/fda-roundup-march-22-2024 | url-status=dead }} {{PD-notice}}{{cite press release | title=Invivyd Announces FDA Authorization for Emergency Use of Pemgarda (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19 | publisher=Invivyd | via=GlobeNewswire | date=22 March 2024 | url=https://www.globenewswire.com/news-release/2024/03/22/2851117/0/en/Invivyd-Announces-FDA-Authorization-for-Emergency-Use-of-PEMGARDA-Formerly-VYD222-for-Pre-exposure-Prophylaxis-PrEP-of-COVID-19.html | access-date=23 March 2024 | archive-date=23 March 2024 | archive-url=https://web.archive.org/web/20240323211051/https://www.globenewswire.com/news-release/2024/03/22/2851117/0/en/Invivyd-Announces-FDA-Authorization-for-Emergency-Use-of-PEMGARDA-Formerly-VYD222-for-Pre-exposure-Prophylaxis-PrEP-of-COVID-19.html | url-status=live }}

Medical uses

In the US, pemivibart is authorized for the pre-exposure prophylaxis (prevention) of COVID{{nbhyph}}19 in people aged twelve years of age and older weighing at least {{convert|40|kg|lb}}. It is authorized for individuals who are not currently infected with SARS{{nbhyph}}CoV{{nbhyph}}2 and who have not had a known recent exposure to an individual infected with SARS{{nbhyph}}CoV{{nbhyph}}2; and who have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID{{nbhyph}}19 vaccination.

In August 2024, the US Food and Drug Administration (FDA) revised the emergency use authorization for pemivibart to limit its use to when the combined national frequency of variants with substantially reduced susceptibility to pemivibart is less than or equal to 90%.{{cite press release | title=FDA Roundup: August 27, 2024 | website=U.S. Food and Drug Administration (FDA) | date=27 August 2024 | url=https://www.fda.gov/news-events/press-announcements/fda-roundup-august-27-2024 | access-date=27 August 2024}} {{PD-notice}}{{cite web | title=Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products | website=U.S. Food and Drug Administration (FDA) | date=11 May 2023 | url=https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products | archive-url=https://web.archive.org/web/20230314011233/https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products | url-status=dead | archive-date=14 March 2023 | access-date=27 August 2024}}

Society and culture

= Legal status =

The US Food and Drug Administration (FDA) issued an emergency use authorization for pemivibart in March 2024.{{cite web | title=CDER Scientific Reviews Supporting EUA for Therapeutic Products | website=U.S. Food and Drug Administration (FDA) | date=1 October 2024 | url=https://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological | archive-url=https://web.archive.org/web/20210315210133/https://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological | url-status=dead | archive-date=15 March 2021 | access-date=17 October 2024}}

= Names =

Pemivibart is the international nonproprietary name.{{cite journal | vauthors = ((World Health Organization)) | year = 2024 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 91 | journal = WHO Drug Information | volume = 38 | issue = 1 | hdl = 10665/378096 | hdl-access = free | author-link = World Health Organization }}

References

Category:Antiviral drugs

Category:Experimental monoclonal antibodies

Category:COVID-19 drug development