U.S. Suspends Distribution of Eli Lilly COVID-19 Antibody Cocktail

HHS has stopped shipping Eli Lilly’s COVID-19 antibody cocktail (bamlanivimab/etesevimab) because of the therapy’s lack of effectiveness against new variants of SARS-CoV-2.

The department made the decision after the cocktail failed to show efficacy in laboratory analyses against the variants first identified in Brazil and South Africa, which now account for over 11 percent of COVID-19 infections in the U.S.

HHS previously halted U.S. deliveries of bamlanivimab in late March because the antibody wasn’t effective against certain coronavirus variants (DID, March 29), and the FDA later revoked bamlanivimab’s Emergency Use Authorization as a COVID-19 monotherapy.

The U.S. government also revised its deal with Lilly to continue shipping the combination therapy — and phase 3 trial results showed the cocktail reduced the risk of COVID-19-related and hospitalization and death by 87 percent, and demonstrated efficacy against variants (DID, April 13).

But the FDA now recommends patients use Regeneron Pharmaceuticals’ antibody cocktail REGEN-COV (casirivimab/imdevimab) and Vir Biotechnologies’ and GlaxoSmithKline (GSK)’s sotrovimab for COVID-19 patients at high-risk of progressing to severe disease (DID, June). The agency also approved Roche’s anti-inflammatory drug Actemra (tocilizumab) last week for treating at-risk hospitalized COVID-19 patients (DID, June 28).

Lilly did not challenge the HHS decision on bamlanivimab/etesevimab, but said it will continue to “work with governments and regulators worldwide” to ensure the antibodies “are available to appropriate patients.” ― Jason Scott