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HHS halts distribution of Lilly’s bamlanivimab/etesevimab antibody cocktail

By Brian Buntz | June 25, 2021

HHS
U.S. government authorities have decided to immediately pause the distribution of Eli Lilly’s bamlanivimab and etesevimab over concerns that the monoclonal antibody cocktail is ineffective against some SARS-CoV-2 variants.

CDC recently concluded that the Gamma variant (P.1) and the Beta variant (B.1.351) make up 11% of COVID-19 infections. They are also continuing to become more dominant, as is the Delta variant (B.1.617.2). CDC has determined that the Delta variant is possibly less responsive to some monoclonal antibody treatments.

The Beta and Gamma variants are significantly less responsive to bamlanivimab and etesevimab than other viral lineages.

bamlanivimab and etesevimab

Bamlanivimab and etesevimab image courtesy of Lilly.

FDA is recommending Regeneron’s REGEN-COV and GSK’s sotrovimab as more robust antibody therapies.

In related news, FDA recently granted emergency use authorization to tocilizumab, a monoclonal antibody from Roche.

In April, FDA had revoked the emergency use authorization for bamlanivimab alone as a COVID-19 treatment, recommending the combination of bamlanivimab and etesevimab instead.

In May, HHS had paused the use of the bamlanivimab/etesevimab cocktail due to surging viral variants in several states.


Filed Under: Infectious Disease, Uncategorized
Tagged With: B.1.351, B.1.617.2, Beta variant, coronavirus, covid-19, Delta variant, Eli Lilly, Eli Lilly & Co., FDA, Gamma variant, investigational monoclonal antibody, monoclonal antibody, P.1, SARS-CoV-2 variants
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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