Eli Lilly antibody treatment stopped due to spread of COVID-19 variants

coronavirus COVID-19 us food and drug administration emergency use authorization EUA Eli Lilly bamlanivimab experimental severe allergic reactions clinical trials phase 2 president trump infection
Getty Images

The U.S. government has stopped the use of Eli Lilly’s COVID-19 monoclonal antibody treatments due to the spread of COVID-19 variants.

The announcement about bamlanivimab came Wednesday from the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.

The announcement only applies to bamlanivimab used alone. It can still be used in combination with etesevimab, which is another monoclonal antibody. 

CNN reported that the government has sent out nearly 800,000 doses bamlanivimab as of March 2.

“Given the sustained increase in SARS-CoV-2 viral variants in the United States that are resistant to bamlanivimab administered alone, and the availability of other authorized monoclonal antibody therapies that are expected to retain activity to these variants, the U.S. Government, in coordination with Eli Lilly and Company will stop the distribution of bamlanivimab alone,” the statement said.

The statement also said that the Food and Drug Administration (FDA) has updated its guidance on bamlanivimab, advising health care providers to consider alternative authorized monoclonal antibodies that can withstand circulating variants.

In a statement to The Hill, Eli Lilly said, “We recognize the U.S. government has made the decision to no longer allow direct ordering of bamlanivimab alone due to concerns about the prevalence of the California (B.1.427/B.1.429) and New York (B.1.526) variants of SARS-CoV-2.”

Lilly developed bamlanivimab and etesevimab for administration together to be prepared for the spread of SARS-CoV-2 variants that could resist treatment with either monoclonal antibody alone,” the statement said. “We believe that sites with access to bamlanivimab and etesevimab for administration together should use that therapy over bamlanivimab alone.”

The FDA issued an emergency-use authorization for bamlanivimab in early November for people who weigh at least 40 kilograms and are at high risk for developing severe COVID-19. It authorized the antibody with etesevimab in February for mild or moderate COVID-19 cases.

Eli Lilly released a study earlier in March finding that the combination reduced the risk of hospitalization and death from COVID-19 by 87 percent. 

Tags Coronavirus COVID-19 Department of Health and Human Services Eli Lilly Food and Drug Administration Monoclonal antibodies Treatment and management of COVID-19

Copyright 2024 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed..

Main Area Top ↴
Main Area Middle ↴
Main Area Bottom ↴

Top Stories

See All

Most Popular

Load more

Video

See all Video