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FDA: Bebtelovimab no longer authorized to treat COVID

November 30, 2022

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Health officials have removed authorization of COVID treatment bebtelovimab in all regions.

The anti-SARS-CoV-2 monoclonal antibody previously authorized for use in patients 12 years and older with SARS-CoV-2 is not expected to neutralize omicron subvariants BQ.1 and BQ.1.1, according to the Food and Drug Administration (FDA). The two subvariants now account for about 57% of cases nationally and at least half of the SARS-CoV-2 viruses circulating in nearly all individual regions of the U.S.

Anyone with a supply of bebtelovimab should keep it in proper storage conditions in the event it can be used to treat future variants.

Clinicians treating children with mild to moderate COVID who are at risk for progression to severe disease can continue using Paxlovid (nirmatrelvir and ritonavir) for those 12 and older weighing at least 40 kilograms (kg) or Veklury (remdesivir) for patients 28 days and older weighing at least 3 kg.

Patients with immunosuppressive disease or receiving immunosuppressive treatment may be eligible for COVID-19 convalescent plasma that has high titers of anti-SARS-CoV-2 antibodies.



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