Eli Lilly’s Covid-19 antibody bamlanivimab already lost its solo FDA authorization as viral variants emerged. Now, the company’s two-antibody combo is facing another challenge.
Federal officials are pausing delivery of the bamlanivimab-etesevimab cocktail to Illinois as a result of fears about one specific variant called P.1.
In a notice sent out early May, authorities expressed concerns about the combo’s effectiveness against that variant, first identified in Brazil. The Office of the Assistant Secretary for Preparedness and Response affirmed it is pausing distribution of the antibody cocktail, plus etesevimab only, in the state.
The Centers for Disease Control and Prevention found that the P.1 variant is “circulating with increasing frequency” in Illinois, ASPR and the FDA disclosed in a joint notice. In vitro studies have asserted that Lilly’s combo medicine is “not active against the P.1 variant,” they added.
On the other side, Regeneron’s Regen-Cov has the same emergency use authorization and is “likely to retain activity against the P.1 variant,” ASPR disclosed, based on similar studies.
“The FDA recommends that healthcare providers in the State of Illinois use this alternative authorized monoclonal antibody therapy until further notice,” the notice noted.
Both antibody combos are authorized for newly diagnosed patients at a high risk of developing severe disease. The development doesn’t affect other states, including those close to Illinois, authorities confirmed.
An Eli Lilly representative said the company understands the government’s decision, and that recent data indicate its combo can neutralize most variants in the U.S.
“Therefore, we believe that sites outside Illinois with access to bamlanivimab administered with etesevimab together can continue to use the available therapy,” she disclosed.
The development comes on the back of the decision by FDA to halt distribution of Eli Lilly’s solo antibody, bamlanivimab, first in three states and then countrywide, over variant fears.
Responding to that news, a Lily rep previously noted it’s “always been our view that additional antibodies from Lilly and others will need to be developed to address the evolution of the virus, including emerging variants that can differ by country or even by state.”
That belief spurred the company’s push for a combo antibody and “continues to underpin our strategy moving forward.”
With Lilly’s antibody combo showing susceptibility to one troublesome variant, it is yet to be seen how the company will move forward.