USA – EUA for COVID antibody calls for additional plant oversight

The US Food and Drug Administration (FDA) has granted an emergency use authorization for an outpatient therapy to treat mild to moderate COVID-19. The monoclonal antibody, bamlanivimab, is authorized for outpatient use in adults and pediatric patients who are at least 12 years old and weigh at least 40 kg.
 
The treatment is reserved for patients who have positive direct SARS-CoV-2 viral tests – not antigen tests – and who are “at high risk for progressing to severe COVID-19 and/or hospitalization,” according to the FDA’s 9 November letter of authorization issued to bamlanivimab’s sponsor, Eli Lilly and Company. In announcing the emergency use authorization (EUA), FDA noted that high risk conditions can include obesity, other chronic medical problems and being 65 years old, or older.
 
The newly authorized treatment is a neutralizing IgG1 monoclonal antibody that binds to the spike protein of the SARS-CoV-2 virus. It must be administered by infusion and it must be kept at refrigerated temperatures and away from light until use, though it may be held at room temperature for a total of 7 hours, including the time required to infuse the antibody. Administration must occur in a setting that can manage severe infusion reactions including anaphylaxis…