On March 22, the FDA granted emergency use authorization to Pemgarda, a COVID-19 preventive medication, for patients 12 and older.
Pemgarda (pemivibart) is a monoclonal antibody that targets the SARS-CoV-2 spike protein. Clinicians are authorized to administer the drug, which must be infused for at least an hour and be followed by a repeat dose every three months. It is authorized for use in patients who are immunocompromised because of a medical condition, or those who are taking immunosuppressive medications and are unlikely to be protected with a COVID-19 vaccine.
In an ongoing phase 3 trial, the "calculated serum neutralizing antibody titers against JN.1" matched efficacy data for other monoclonal antibody products, the Massachusetts-based manufacturer, Invivyd, said in a news release.
Side effects include hypersensitivity, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache and nausea; and its warning label lists anaphylaxis and cross-hypersensitivity with COVID-19 vaccines.