FDA green light for GSK and Vir's sotrovimab in COVID-19

The US Food and Drug Administration has granted an Emergency Use Authorization (EUA) for sotrovimab (previously VIR-7831), an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate COVID-19, developed by UK pharma major GlaxoSmithKline (LSE: GSK) and the USA’s Vir Biotechnology (Nasdaq: VIR).

In April 2020, to gain access to Vir’s technology, GSK made an equity investment of $250 million in the US firm, whose shares leapt nearly 17% to $53.35 in after-hours trading yesterday. GSK was barely changed.

The product is cleared for use in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.