Eli Lilly's COVID-19 antibody bamlanivimab already lost its solo FDA authorization as viral variants cropped up. Now, the company's two-antibody combo is running into trouble.
Federal officials are pausing shipments of the bamlanivimab-etesevimab cocktail to Illinois because of worries about one specific variant called P.1.
In a notice last week, authorities raised concerns about the combo's effectiveness against that variant, first identified in Brazil. The Office of the Assistant Secretary for Preparedness and Response said it is pausing distribution of the antibody cocktail, plus etesevimab alone, in the state
The Centers for Disease Control and Prevention saw that the P.1 variant is "circulating with increasing frequency" in Illinois, ASPR and the FDA said in a joint notice. In vitro studies have indicated that Lilly's combo medicine is "not active against the P.1 variant," they added.
On the flip side, Regeneron's Regen-Cov carries the same emergency use authorization and is "likely to retain activity against the P.1 variant," ASPR said, 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 said.
Both antibody combos are authorized for newly diagnosed patients at a high risk of developing severe disease. The move doesn't affect other states, including those near Illinois, authorities said.
An Eli Lilly representative said the company recognizes the government's decision, and that recent data show its combo can neutralize the majority of 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 said.
The move comes after the feds halted distribution of Eli Lilly's solo antibody, bamlanivimab, first in three states and then nationwide, over variant concerns.
Responding to that news, a Lilly representative previously said 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 drove 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 remains to be seen how the company will proceed.
Meanwhile, COVID-19 vaccines are rolling out at an impressive clip in the United States. More than 264 million doses have been administered, and nearly 60% of adults have had at least one dose. Pfizer's vaccine just scored an FDA emergency authorization in children, helping to widen the eligible population for shots, as well.
Even as vaccines reach more and more Americans, Regeneron's CEO recently said he expects an extended need for monoclonal antibodies, both for people who don't get vaccines, and for people who need more protection.
Eli Lilly reported $810 million in global COVID-19 antibody sales during the first quarter, while Regeneron reported $439 million.