FDA pulls GSK, Vir antibody treatment EUA

April 6, 2022

The U.S. FDA has updated the EUA for GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody treatment, dropping the authorization as the new omicron sub-variant reduced its effectiveness.

The sub-variant, BA.2 is highly contagious and is now estimated to be about three of every four COVID-19 cases in the U.S. The treatment, called sotrovimab, does not appear to work well against the new variant, according to the FDA. 

GSK and Vir, for their parts, have said that the monoclonal antibody can still be effective against the sub-variant. Others, like researchers at Columbia University, agree with the agency saying that it is not effective, as reported by Reuters.

Despite the loss of EUA status, Vir still expects to pull in about $1.1 billion in collaboration revenue once sotrovimab doses are delivered, which should be before July.

GSK and Vir are planning to apply for full approval of sotrovimab in the later part of 2022. The drug was first granted emergency use authorization back in May of 2021, for the treatment of mild-to-moderate COVID-19 in pediatric and adult patients.

In addition to seeking full approval, the companies will start looking into whether the treatment can prevent symptomatic COVID-19 infection in immunocompromised patients. The two late-stage trials will start between April and June.