Lilly's COVID antibody combo halted nationwide, dealing huge blow to blockbuster program

Eli Lilly's COVID-19 antibody cocktail has already been on the outs in several states over fears of reduced variant efficacy. Now, the U.S. has decided to extend that policy nationwide.

With a pair of troubling coronavirus variants on the rise, the U.S. is pausing the national distribution of Eli Lilly’s COVID-19 antibody combo of bamlanivimab and etesevimab until further notice, the HHS Assistant Secretary for Preparedness and Response said Friday.

The Centers for Disease Control and Prevention has warned that together, the SARS-COV-2 Gamma variant, first identified in Brazil, and the Beta variant, which originally surfaced in South Africa, now make up more than 11% of sequenced U.S. coronavirus cases. That figure is ticking up, the CDC said. 

In an unfortunate blow for Lilly, which was the first company to score an FDA emergency nod for a COVID-19 antibody drug, in vitro assays have shown that bamlanivimab and etesevimab together "are not active against either" variant, according to an ASPR release.

In lieu of Lilly's antibody combo, the U.S. recommends healthcare providers switch to other authorized monoclonal antibody drugs like Regeneron's cocktail REGEN-COV and GlaxoSmithKline and Vir Biotechnology's solo agent sotrovimab.  

Similar in vitro assay data have shown REGN-COV and sotrovimab are "likely to retain activity" against both the Gamma and Beta variants, ASPR's release noted. 

Lilly did not immediately respond to Fierce Pharma's request for comment. 

RELATED: Eli Lilly's COVID-19 antibody halted in 6 more states as Regeneron's competing option sails along

The news isn't a complete surprise, as officials had already halted distribution of the antibody cocktail in numerous states on concerns of reduced efficacy against variants. In late May, after prior halts in Illinois and Massachusetts, officials paused shipments to Arizona, California, Florida, Indiana, Oregon and Washington. 

Still, the nationwide halt throws Eli Lilly's future antibody plans completely up into the air. At the start of the year, the company expected sales of $1 billion to $2 billion for its coronavirus antibodies. During the first quarter, the combo posted $810 million in revenues. 

During last year's fourth quarter, Lilly posted COVID antibody sales of $871 million. 

Meanwhile, Regeneron's competing COVID antibody has been sailing ahead, recently scoring FDA endorsements for a lower dose and a subcutaneous injection dosing option. And more competition hit the scene, with GlaxoSmithKline and Vir Biotechnology's emergency use authorization for sotrovimab in late May.