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FDA pulls authorization for GSK-Vir’s COVID therapy as BA.2 cases rise -Breaking

by Mike Robinson

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© Reuters. FILE PHOTO A view of GlaxoSmithKline Headquarters in London, Britain. January 17, 2022. REUTERS/Hannah McKay

(Reuters) -A U.S. regulator stated Tuesday that GlaxoSmithKline and Vir Biotechnology were no longer allowed to use their antibody therapy as a COVID-19 procedure. Data suggests it is unlikely to work against the Omicron dominant sub-variant.

Last month, the agency withdrew its authorization to sotrovimab in the northeastern United States.

Based on the most recent government data, it is believed that the extremely contagious BA.2 coronavirus variant makes up around three out of four COVID-19-related cases in the United States.

GlaxoSmithKline, Vir and others have stated that sotrovimab treatment remains neutralizing against the BA.2 subvariant. However, Columbia University researchers disagree.

Lyndsay Meyer from GSK stated Tuesday that COVID will evolve as new variants are discovered and it is expected that governments and other health care systems will require a wide range of therapeutic and vaccine options. GSK will also continue working with these entities to provide sotrovimab access.

Shares in Vir Biotechnology fell almost 10% during afternoon trading.

The companies stated last month that they had prepared a set of data to support a higher sotrovimab dose than the 500m currently allowed for the BA.2 subvariant.

GlaxoSmithKline and Vir felt high demand for sotrovimab, which was the only COVID treatment that has been proven to be effective against Omicron variants.

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