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FDA amends EUA for SARS-CoV-2 antibody sotrovimab

By Brian Buntz | March 25, 2022

GSK–VirGlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) have announced that FDA has concluded that the investigational monoclonal antibody sotrovimab is unlikely to be effective against the omicron BA.2 subvariant, which will soon dominate the U.S.

FDA has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab and its website to exclude the antibody in certain areas.

GSK and Vir were initially optimistic about the antibody’s ability to target the mutations in the spike protein of the original omicron SARS-CoV-2 variant.

Vir shares dropped 13.56% to $21.81. GSK shares were mostly flat, falling 0.046% to $43.28.

The market for SARS-CoV-2 antibodies has been competitive, but emerging variants have limited use of the therapies.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently recommended marketing authorization for AstraZeneca’s (LON:AZN) Evusheld to protect against COVID-19 in adults and some adolescents.


Filed Under: Infectious Disease
Tagged With: coronavirus, covid-19, COVID-19 vaccine, FDA, GSK, sotrovimab, Vir Biotechnology
 

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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