UPDATED: US pauses use of Eli Lilly's Covid-19 treatment nationwide due to variants
Due to the presence of variants, the US said Friday that it’s pausing shipments of Eli Lilly’s monoclonal antibody combo for the treatment of Covid-19 on a national basis until further notice.
The pause, which could amount to the loss of about $375 million in sales according to one biotech analyst, is another blow to Lilly’s efforts to treat Covid-19 outside of the hospital, as the company previously had its EUA for bamlanivimab revoked.
“The CDC identified that the combined frequencies of the SARS-CoV-2 P.1/Gamma variant (first identified in Brazil) and the B.1.351/Beta variant (first identified in South Africa) throughout the United States now exceed 11% and are trending upward,” John Redd, CMO of the Office of the Assistant Secretary for Preparedness and Response, said in a letter obtained by Endpoints News.
“Results from in vitro assays that are used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that bamlanivimab and etesevimab administered together are not active against either the P.1 or B.1.351 variants,” Redd wrote.
Previously, distribution of the combo of bamlanivimab and etesevimab was halted in 9 states, including Arizona, California, Florida, Indiana, Oregon, Illinois, Massachusetts, Rhode Island and Washington, as the combined frequency of the Covid-19 variants first identified in Brazil and South Africa exceeded 10% then.
Lilly said in an emailed statement, “Bamlanivimab and etesevimab administered together do not retain neutralization effects against the Gamma or Beta variant. The U.S. Food and Drug Administration (FDA) recommends that health care providers in the U.S. use alternative authorized monoclonal antibody therapies until further notice. As we have seen over the last several months, prevalence of variants varies by state, region and even country and can change rapidly. Lilly continually monitors the global COVID-19 environment, assessing the neutralization of our antibody therapies against a wide array of existing and emerging mutations and variants as well as the available therapies.”
States will still have the option of using two monoclonal antibodies developed by Regeneron and Vir/GSK as the variants do not evade either of those treatments as well as they did with the Lilly treatments.
Bernstein biotech analyst Ronny Gal said in a note to investors late last month that the market will now likely shift in Regeneron’s favor.
Editor’s note: Article updated with comment from Lilly.