GlaxoSmithKline plc (GSK) and California-based Vir Biotechnology, Inc. announced that the European Medicines Agency (EMA) had started a rolling review of data on an investigational compound known as Sotrovimab (VIR-7831), a dual-action SARS-CoV-2 monoclonal antibody.
The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1, indicating that the epitope is highly conserved and less likely to mutate over time. Sotrovimab, which incorporates Xencor’s Xtend™ technology, also has 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.
The EMA will evaluate all data on Sotrovimab, including evidence from clinical trials, as they become available.
The EMA's decision to start the rolling review is based on the interim analysis of efficacy and safety data from the Phase 3 COMET-ICE clinical trial, which evaluated Sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. The interim analysis demonstrated an 85% reduction in hospitalizations over 24 hours or deaths in those receiving Sotrovimab.
The companies submitted an Emergency Use Authorization application for Sotrovimab to the US Food and Drug Administration. Sotrovimab is also under review by other global regulators, including Health Canada. Sotrovimab has not been granted a marketing authorization anywhere globally.
In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses. GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. For further information, please visit www.gsk.com/about-us.