FDA issues EUA for bamlanivimab to treat COVID-19

On November 10, FDA issued an emergency use authorization (EUA) to Eli Lilly for the investigational monoclonal antibody therapy bamlanivimab to treat mild to moderate COVID-19 in adult and pediatric patients.

Bamlanivimab is authorized for patients ages 12 years and older who test positive for SARS-CoV-2 virus, weigh at least 40 kg (about 88 lb), and are at high risk for progressing to severe COVID-19 and/or hospitalization. It is also authorized for adults ages 65 years or older or those who have certain chronic medical conditions.

The EUA allows for bamlanivimab to be distributed and administered as a single dose intravenously by health care providers. According to the EUA, fact sheets that provide important information about using bamlanivimab in treating COVID-19—including dosing instructions, potential adverse effects, and drug interactions—must be made available to health care providers and to patients and caregivers. Possible adverse effects include anaphylaxis and infusion-related reactions, nausea, diarrhea, dizziness, headache, itching, and vomiting.

Bamlanivimab is not authorized for COVID-19 patients who are hospitalized or require oxygen therapy because a benefit of bamlanivimab treatment has not been shown in these patients. Monoclonal antibodies such as bamlanivimab may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 who require high-flow oxygen or mechanical ventilation.