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FDA halts COVID-19 antibody treatment for some states

Shown is the American headquarters of British drugmaker GlaxoSmithKline PLC, in Philadelphia, Wednesday, Nov. 5, 2008. The world's No. 2 drugmaker, measured by sales, also will switch from having dual U.S. headquarters, in Philadelphia and in Research Triangle Park, N.C., to operating just the North Carolina headquarters. (AP Photo/Matt Rourke)

Story at a glance

  • New data on sotrovimab, one of the few antibody treatments available, suggest it is not as effective on the BA.2 omicron subvariant.
  • The government has paused shipments to two regions in northeastern U.S.
  • An antibody treatment authorized by the FDA last month seems to work against the BA.2 subvariant, although it is still limited in supply.

The U.S. Federal Drug Administration (FDA) updated last Friday the use authorization for the monoclonal antibody treatment sotrovimab from GlaxoSmithKline and Vir Biotechnology, limiting its use.  

In a statement, the agency said that the treatment is no longer authorized for use in several states in New England and the New York, New Jersey area. Shipments of the drug to those states have also been paused, according to the Department of Health & Human Services (HHS). 

These changes follow new data that suggest that the monoclonal antibody treatment is not as effective on the BA.2 subvariant as original omicron and previous variants.  In a study published in Nature, researchers found that the BA.2 strain was resistant to 17 out of 19 antibody treatments in a laboratory setting. 


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Earlier this year during the original omicron surge in the U.S., shipments of other antibody treatments were paused for similar reasons that they were not as effective on the new variant.

A newly authorized antibody treatment may be able to step in now that sotrovimab and other treatments seem to be ineffective. Last month, the FDA approved emergency use authorization for bebtelovimab to be prescribed to people with mild to moderate illness. The Nature study authors found that only the recently authorized bebtelovimab could adequately cover all omicron sublineages. 

The government has ordered 600,000 treatment courses of the drug, according to HHS. More than 306,00 of these have been distributed as of this week, according to data from the agency. 

There’s evidence that another already authorized antibody treatment may be effective against BA.2. A pre-print study that has not yet been peer reviewed found that the mixture of two types of antibodies in Evusheld (AZD8895+AZD1061) “retained substantial neutralizing power” against the BA.2 subvariant. However, this treatment is meant to be given prior to exposure to the SARS-CoV-2 coronavirus. It is meant to help immunocompromised individuals before potential infection and not meant to be given to people after they have tested positive.


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Published on Mar 29,2022