US further limits access to GSK's antibody

The U.S. is further restricting access to GlaxoSmithKline's COVID-19 antibody drug sotrovimab in response to research suggesting it is ineffective against the omicron subvariant BA.2, now the country's dominant strain.

The FDA updated its emergency use authorization for sotrovimab March 30, saying the following HHS regions are no longer authorized to treat high-risk patients with the drug:

  • Region 5: Illinois, Indiana, Michigan, Minnesota, Ohio and Wisconsin
  • Region 9: Arizona, California, Hawaii, Nevada, American Samoa, Northern Mariana Islands, Micronesia, Guam, Marshall Islands and Palau 
  • Region 10: Alaska, Idaho, Oregon and Washington 

The U.S. first paused shipments to HHS Region 1 (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont) and Region 2 (New Jersey, New York, Puerto Rico and the Virgin Islands) March 25.

The drug is still authorized in five regions where BA.2 accounted for less than 50 percent of new cases, according to CDC estimates, as of March 30. 

View the full update here.

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