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]
^World Health Organization (2024). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 91". WHO Drug Information. 38 (1). hdl:10665/378096.