Pemivibart, sold under the brand name Pemgarda, is a
monoclonal antibody
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell.
Monoclonal antibodie ...
medication authorized for the
pre-exposure prophylaxis
Pre-exposure prophylaxis (PrEP), is the use of medications to prevent the spread of disease in people who have not yet been exposed to a disease-causing agent. Vaccination is the most commonly used form of pre-exposure prophylaxis; other forms of ...
(prevention) of
COVID19.
Pemivibart was developed by
Invivyd.
The US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) issued an
emergency use authorization for pemivibart in March 2024.
[ ]
Medical uses
In the US, pemivibart is authorized for the pre-exposure prophylaxis (prevention) of COVID19 in people aged twelve years of age and older weighing at least .
It is authorized for individuals who are not currently infected with
SARSCoV2 and who have not had a known recent exposure to an individual infected with SARSCoV2; 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 COVID19 vaccination.
In August 2024, the US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(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%.
Society and culture
Legal status
The US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) issued an
emergency use authorization for pemivibart in March 2024.
Names
Pemivibart is the
international nonproprietary name.
References
{{Authority control
Antiviral drugs
Experimental monoclonal antibodies
COVID-19 drug development