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FDA Pulls GlaxoSmithKline’s Antibody Drug as Omicron Subvariant BA.2 Dominates U.S. COVID-19 Cases

GlaxoSmithKline’s IV drug for COVID-19 should no longer be used because it is likely ineffective against the Omicron subvariant BA.2 that now accounts for most cases in the US, federal regulators said on Tuesday (April 5).

The FDA has announced that the company’s antibody sotrovimab is no longer cleared to treat patients in any US state or territory. The FDA had already repeatedly restricted the drug’s use in the Northeast and other regions as the BA.2 variant became dominant.

The CDC said on Tuesday that BA.2 now accounts for 72% of COVID-19 cases sequenced by health authorities.

The drug from Glaxo and co-developer Vir Biotechnology is the latest antibody drug to be sidelined by variants of SARS-CoV-2. The FDA previously withdrew authorization of drugs from Eli Lilly and Regeneron in January after concluding that they were ineffective against the original version of Omicron.

The decision leaves doctors and hospitals with only one antibody treatment still authorized for use against COVID-19: another Eli Lilly drug that regulators say appears effective against BA.2.

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