Pemivibart
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | Spike protein of SARS-CoV-2 |
| Clinical data | |
| Trade names | Pemgarda |
| Other names | VYD222 |
| AHFS/Drugs.com | Monograph |
| License data |
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| Routes of administration | Intravenous |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
Pemivibart, sold under the brand name Pemgarda, is a monoclonal antibody medication authorized for the pre-exposure prophylaxis (prevention) of COVID‑19.[4] Pemivibart was developed by Invivyd.[3][5]
The US Food and Drug Administration (FDA) issued an emergency use authorization for pemivibart in March 2024.[4][5]
Medical uses
[edit]In the US, pemivibart is authorized for the pre-exposure prophylaxis (prevention) of COVID‑19 in people aged twelve years of age and older weighing at least 40 kilograms (88 lb).[4] It is authorized for individuals who are not currently infected with SARS‑CoV‑2 and who have not had a known recent exposure to an individual infected with SARS‑CoV‑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‑19 vaccination.[4]
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%.[2][3][6][7]
Society and culture
[edit]Legal status
[edit]The US Food and Drug Administration (FDA) issued an emergency use authorization for pemivibart in March 2024.[4][7][8]
Names
[edit]Pemivibart is the international nonproprietary name.[9]
References
[edit]- ^ "Pemgarda- pemivibart injection". DailyMed. 22 March 2024. Retrieved 17 October 2024.
- ^ a b "Emergency Use Authorization: Pemgarda (pemivibart)". U.S. Food and Drug Administration (FDA). 22 March 2024.
- ^ a b c "Highlight of Emergency Use Authorization: Pemgarda (pemivibart)". U.S. Food and Drug Administration (FDA). Archived from the original on 23 March 2024. Retrieved 23 March 2024.
- ^ a b c d e "FDA Roundup: March 22, 2024". U.S. Food and Drug Administration (FDA). 22 March 2024. Archived from the original on 23 March 2024. Retrieved 23 March 2024.
This article incorporates text from this source, which is in the public domain. - ^ a b "Invivyd Announces FDA Authorization for Emergency Use of Pemgarda (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19" (Press release). Invivyd. 22 March 2024. Archived from the original on 23 March 2024. Retrieved 23 March 2024 – via GlobeNewswire.
- ^ "FDA Roundup: August 27, 2024". U.S. Food and Drug Administration (FDA) (Press release). 27 August 2024. Retrieved 27 August 2024. This article incorporates text from this source, which is in the public domain.
- ^ a b "Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products". U.S. Food and Drug Administration (FDA). 11 May 2023. Retrieved 27 August 2024.
- ^ "CDER Scientific Reviews Supporting EUA for Therapeutic Products". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 17 October 2024.
- ^ World Health Organization (2024). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 91". WHO Drug Information. 38 (1). hdl:10665/378096.
This article incorporates public domain material from the United States Department of Health and Human Services
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