U.S. Pauses Use of Lilly’s Monoclonal Antibody Combo for COVID

The U.S. government will pause distribution of the monoclonal antibodies bamlanivimab and etesevimab, authorized for high-risk COVID-19 outpatients, citing poor performance against variants, health officials announced on Friday.

HHS’s office of the Assistant Secretary for Preparedness and Response (ASPR) said they were halting distribution of bamlanivimab and etesevimab together, as well as etesevimab separately, on a national basis. Previously, nine states had already paused distribution. The statement recommended clinicians use a separate monoclonal antibody treatment for COVID-19 patients.

Bamlanivimab and etesevimab as a combination therapy was previously authorized in February under emergency use authorization (EUA) for COVID-19 patients at high risk of severe disease. FDA revoked the EUA for bamlanivimab as monotherapy for this group of patients in April.

In vitro data on the combination found the therapy was “not active against either the P.1 [Gamma] or B.1.351 [Beta] variants,” which as the statement noted, now comprise 11% of COVID cases in the U.S., and counting.

Manufacturer Eli Lilly responded in an emailed statement to Endpoints News, acknowledging that, “bamlanivimab and etesevimab administered together do not retain neutralization effects against the Gamma or Beta variant.”

However, the manufacturer added that, “as we have seen over the last several months, prevalence of variants varies by state, region and even country and can change rapidly.”

The ASPR statement recommends clinicians use either ​casirivimab and imdevimab (REGEN-COV) or sotrovimab, which “are likely to retain activity against the P.1 or B.1.351 variants” based on current in vitro data. Both therapies are also authorized under EUA to treat COVID-19 patients.

Last Updated June 28, 2021