FDA pulls authorization for GSK-Vir's COVID therapy amid rising BA.2 cases

The U.S. health regulator said on Tuesday GlaxoSmithKline and Vir Biotechnology's antibody therapy was no longer authorized to treat COVID-19 in the U.S. due to an increase in the proportion of cases caused by the Omicron sub-variant. The agency pulled its authorization for the therapy sotrovimab in much of the U.S. northeast last month.

The U.S. health regulator said on Tuesday GlaxoSmithKline and Vir Biotechnology's antibody therapy was no longer authorized to treat COVID-19 in the U.S. due to an increase in the proportion of cases caused by the Omicron sub-variant.

The agency pulled its authorization for the therapy sotrovimab in much of the U.S. northeast last month. The highly contagious BA.2 coronavirus sub-variant is estimated to cause about three of every four COVID-19 cases in the U.S. now, according to government data. Vir Biotechnology's shares fell nearly 10% in afternoon trading.

GlaxoSmithKline and Vir have said treatment with sotrovimab retains neutralizing activity against the BA.2 sub-variant, but others, including researchers from Columbia University, found it did not. Last month, the companies said they were preparing a package of data in support of a higher dose for sotrovimab than the currently authorized 500 mg for the BA.2 sub-variant.

The U.S. Food and Drug Administration's move on Tuesday comes as a blow as GlaxoSmithKline and Vir saw high demand for sotrovimab after it became one of the few COVID-19 treatments shown to have worked against the Omicron variant. The companies did not immediately respond to a Reuters request for comment.