The US government has entered into purchase agreements, totaling approximately $1 billion, with GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based bio/pharmaceutical company, for sotrovimab, an investigational monoclonal antibody for treating adults and adolescents with COVID-19.

GSK will supply the doses under the contracts to the US government by December 17, 2021. In addition to the doses that will be supplied this year (2021), the US government will have the option to purchase additional doses through March 2022. Including these contracts with the US government, GSK and Vir have received binding agreements for the sale of more than 750,000 doses of sotrovimab globally, with additional doses reserved through other agreements, including a previously announced joint procurement agreement with the European Commission.

The US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to sotrovimab in May 2021. The companies plan to progress regulatory submissions globally, including ongoing discussions with the FDA regarding the existing EUA for sotrovimab.

Separately, GSK and Vir reported data from a Phase III trial evaluating intramuscular (IM) administration of sotrovimab that showed that IM administration of sotrovimab was non-inferior to intravenous administration for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalized adults and adolescents (12 years of age and older).

Source: GlaxoSmithKline (supply pact), GlaxoSmithKline (IM results), Vir Biotechnology (supply pact), and Vir Biotechnology (IM results)