GSK and Vir Submit Emergency Use Authorization Application to FDA for Intramuscular Administration of Sotrovimab for the Early Treatment of COVID-19

– If authorized, would provide the option for intramuscular administration of sotrovimab, in addition to currently authorized intravenous administration –

–  Submission follows COMET-TAIL Phase 3 data demonstrating that intramuscular administration of sotrovimab was non-inferior and offered  similar efficacy to intravenous administration for high-risk populations –

PHILADELPHIA and SAN FRANCISCO, Jan. 13, 2022 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the submission of an application to the US Food and Drug Administration (FDA) requesting an amendment to the Emergency Use Authorization (EUA) for sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, to include intramuscular (IM) administration. The EUA for sotrovimab was granted by the FDA in May 2021 as an investigational single-dose intravenous (IV) (500 mg) infusion SARS-CoV-2 monoclonal antibody for the early treatment of COVID-19, and the companies are requesting an expansion to the EUA to also include IM administration (500 mg).

Under the current EUA, sotrovimab can be used for the treatment of mild-to-moderate COVID-19 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.

This submission is based on the Phase 3, randomized, open-label, non-inferiority COMET-TAIL trial, which achieved its primary endpoint, demonstrating that 500mg IM administration of sotrovimab (n=376) was non-inferior and offered similar efficacy to 500 mg IV administration (n=378) for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalized adults and adolescents. Low rates of serious adverse events (≤1% in both arms) were observed in the headline data.

About SotrovimabSotrovimab is an investigational SARS-CoV-2-neutralizing monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor, Inc.’s Xtend™ technology, has also been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About the Sotrovimab Clinical Development Program

• COMET-ICE: a Phase 3, multi-center, double-blind, placebo-controlled trial investigated IV infusion of sotrovimab in adults with mild-to-moderate COVID-19 at high risk of progression to severe disease, who are not hospitalized and not requiring oxygen. The final COMET-ICE trial results in the full trial population of 1,057 participants demonstrated a 79% reduction (adjusted relative risk reduction) (p