GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology Inc (NASDAQ:VIR) have applied to the FDA to include intramuscular (IM) administration to sotrovimab's Emergency Use Authorization (EUA) for COVID-19.
- The FDA granted the EUA for sotrovimab in May 2021 as an investigational single-dose intravenous (IV) (500 mg) infusion SARS-CoV-2 monoclonal antibody for the early treatment COVID-19.
- The companies are now requesting an expansion to the EUA to include IM administration (500 mg).
- Related: GSK, Vir's Intramuscularly-Administered Sotrovimab Shows Efficacy At Par With IV Route In COVID-19.
- Under the current EUA, sotrovimab can be used to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg), who are at high risk for progression to severe COVID-19, including hospitalization or death.
- Also See: US To Purchase 600K Additional Doses of GSK-Vir's COVID-19 Antibody Therapy.
- Price Action: VIR shares are down 1.85% at $39.27, GSK shares are up 0.20% at $45.32 on the last check Thursday.
