The US health regulator said recently the current authorised dose of GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody therapy is unlikely to be effective against the Omicron BA.2 variant.
The agency pulled its authorisation for the therapy, Sotrovimab, in much of the US northeast where the subvariant is dominant.
GSK and Vir said they are preparing a package of data in support of a higher dose for Sotrovimab than the currently authorised 500 mg, for the BA.2 subvariant. The data will be shared with regulatory authorities around the world for discussion.
The FDA’s move comes as a blow to the companies which have seen high demand for Sotrovimab after it became one of the few COVID-19 treatments shown to have worked against the Omicron variant.
GSK and Vir have argued that the treatment retains neutralising activity against the BA.2 sub-variant, but others, including researchers from Columbia University, found it did not.
The FDA also said that Eli Lilly’s newly authorised antibody therapy Bebtelovimab is expected to be effective against the BA.2, along with Merck and Pfizer’s antiviral pills.
The US Centers for Disease Control and Prevention (CDC) has identified that the BA.2 variant is now circulating with a frequency exceeding 50 per cent in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, New York, Puerto Rico and the Virgin Islands.
As a result, the Office of the Assistant Secretary for Preparedness and Response said it would pause distribution of Sotrovimab to these states and Gilead Sciences Inc’s Remdesivir.
Edits by EP News Bureau