FDA authorizes emergency use of pemivibart for COVID-19 prevention
The FDA authorized emergency use of pemivibart for pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg.
Pemivibart (Pemgarda, Invivyd) — a recombinant human monoclonal antibody — is indicated for individuals not infected nor recently exposed to anyone with SARS-CoV-2, and who are moderately or severely immunocompromised due to medical conditions or immunosuppressive drugs and treatments and would be “unlikely to mount an adequate immune response to COVID-19,” Patrizia A. Cavazzoni, MD, director of the Center for Drug Evaluation and Research at the FDA, wrote in her emergency use authorization approval letter provided to the manufacturer.
Pemivibart targets the “SARS-CoV-2 spike protein receptor,” which inhibits the “virus attachment to the human ACE2 receptor host cells,” Cavazzoni wrote in her letter.
The agent did not get authorization as a COVID-19 treatment or for post-exposure prevention of COVID-19.
Pemivibart fills a need after tixagevimab plus cilgavimab (Evusheld, AstraZeneca) had its authorization pulled in January 2023.
“Pre-exposure prophylaxis with Pemgarda is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended,” Cavazzoni wrote. “Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate to severe immune compromise who may derive benefit from COVID-19 vaccination, should receive COVID-19 vaccination.”