FDA Revises EUA for COVID-19 Therapy

The FDA has revised the Emergency Use Authorization (EUA) for Lilly’s bamlanivimab and etesevimab to be administered only in the 22 states in which recent data show the frequency of variants resistant to bamlanivimab and etesevimab is less than or equal to 5%.

The monoclonal antibody combination is authorized for use in states where the frequency of variants resistant to bamlanivimab and etesevimab administered together exceeds 5%. The FDA has a list of the states in which the therapy is authorized here.

The therapy received an EUA for use in mild-to-moderate COVID and not for patients who are hospitalized or require oxygen therapy.

Regulatory officials indicated they will update the list of authorized states based on current variant frequency data from the Center for Disease Control, trends in variant frequency over time, the precision of the estimates and information regarding emerging variants of concern.

The FDA had initially authorized the combination in February 2021, but distribution was paused in June 2021 because the CDC had identified variants of concern increasing in the United States. Results from in vitro assays suggest the bamlanivimab/etesevimab was not active against the Gamma, Beta and Delta variants. The Delta variant is the dominant variant in the United States, and the frequency of identified variants expected to be resistant to bamlanivimab and etesevimab is steadily decreasing.

Bamlanivimab and etesevimab are neutralizing IgG1 monoclonal antibodies that bind to distinct but overlapping epitopes in the receptor binding domain of the spike protein of SARS-CoV2. Monoclonal antibodies re designed to help provide passive immunity.

At present, three monoclonal antibody therapies—bamlanivimab/etesevimab, Regeneron’s REGEN-COV, and GlaxoSmithKline’s sotrovimab—are authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adult and pediatric patients (12 years of age and older) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.