FDA Reauthorizes Eli Lilly Antibodies for COVID-19, But Only in Certain States

The FDA has reissued its emergency use authorization (EUA) for Eli Lilly’s monoclonal antibodies bamlanivimab and etesevimab for treatment of COVID-19 — but only for certain states.

FDA Chief Scientist Denise Hinton said the antibodies can only be used in those states, territories or other U.S. jurisdictions “in which the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5 percent.” As of Aug. 27, only 22 states fit into that category.

The EUA was originally granted in February and but its distribution was restricted in late March due to concerns about an increase in variants of SARS-CoV-2 that are resistant to the drug (DID, March 29). The latest revisions allows the antibodies to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19.

The antibodies may not be given to patients who are already hospitalized due to COVID-19, require oxygen therapy for the disease, or need an increase in baseline oxygen they already receive due to an underlying condition. — Martin Berman-Gorvine