FDA reduces access to sotrovimab as omicron subvariant spreads

Three more Department of Health and Human Services regions are no longer authorized to treat patients at high risk for progressing to severe COVID-19 with sotrovimab because the monoclonal antibody is unlikely to work against the BA.2 variant predominating there, the Food and Drug Administration announced last week. The new regions include: Illinois, Indiana, Michigan, Minnesota, Ohio and Wisconsin (Region 5); Arizona, California, Hawaii, Nevada, American Samoa, Northern Mariana Islands, Micronesia, Guam, Marshall Islands and Palau (Region 9); and Alaska, Idaho, Oregon and Washington (Region 10).  

In other news, FDA Friday updated dosing information in its fact sheet and FAQs for the combination monoclonal antibody therapy Evusheld when used to prevent COVID-19 in certain patients.