HHS Lifts Pause on Lilly’s Monoclonal Antibody Combo, Sort Of

The pause has been lifted on the use of the monoclonal antibody combo bamlanivimab and etesevimab in high-risk COVID-19 outpatients, but only in certain states, health officials announced late Friday.

HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) said that distribution of bamlanivimab/etesevimab administered together is now authorized in states and territories where “the combined frequency of variants resistant” to the therapy is 5% or less.

Officials initially paused use of the therapy in late June due to poor performance against variants.

In vitro testing proved the cocktail is expected to be effective against the Delta variant, but not the Beta, Gamma, “Delta Plus,” or the B.1.621 variant identified in Colombia, the statement noted.

“With the emergence of the B.1.617.2/Delta variant as the dominant variant in the U.S., the frequency of identified variants expected to be resistant to bamlanivimab and etesevimab administered together is steadily decreasing,” health officials said.

Under this criteria, 22 states qualify for resumption of distribution of the the monoclonal antibody combination. The FDA also posted a letter that listed the states, territories, and jurisdictions where use of bamlanivimab and etesevimab is not authorized. However, health officials said if the states currently have a supply of the cocktail, they may reserve it in the event that the combined frequency of variants resistant to it drops to 5% or less.

They reiterated that the therapy is authorized in certain states for patients ages 12 and older with COVID-19 who are at high risk of progressing to severe disease, including hospitalization or death. Health officials added that this does not affect the two other currently authorized monoclonal antibodies, REGEN-COV and sotrovimab, which are likely to retain activity against these variants based on in vitro data, and can continue to be used under terms of emergency use authorization.