| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | Spike protein ofSARS-CoV-2 |
| Clinical data | |
| Trade names | Pemgarda |
| Other names | VYD222 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624061 |
| License data | |
| 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 namePemgarda, is amonoclonal antibody medication authorized for thepre-exposure prophylaxis (prevention) ofCOVID‑19.[4] Pemivibart was developed by Invivyd.[3][5]
The USFood and Drug Administration (FDA) issued anemergency use authorization for pemivibart in March 2024.[4][5]
In the US, pemivibart is authorized for the pre-exposure prophylaxis (prevention) of COVID‑19 in people aged twelve years or older weighing at least 40 kilograms (88 lb).[4] Pemivibart is authorized for individuals who are not currently infected withSARS-CoV-2—the virus that causes COVID-19—and have not been recently exposed to the virus. It is intended for individuals with moderate to severeimmunocompromise due to a medical condition orimmunosuppressive treatment, as they are less likely to respond effectively toSARS-CoV-2 vaccination.[4]
In August 2024, the USFood and Drug Administration (FDA) revised theemergency use authorization for pemivibart to limit its use to when the combined national frequency ofvariants with substantiallyreduced susceptibility to pemivibart is less than or equal to 90%.[2][3][6][7]
The US FDA issued anemergency use authorization for pemivibart in March 2024.[4][7][8]
Pemivibart is theinternational nonproprietary name.[9]
This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain. This article incorporatespublic domain material from the United States Department of Health and Human Services
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