The antibody drug developed by GSK and Vir Biotechnology for use in the early treatment of coronavirus patients has been approved for emergency use by the US Food and Drug Administration (FDA).
For the early treatment of COVID-19 patients at risk of developing severe complications, GSK and the monoclonal antibody drug developed by Vir Biotechnology were granted an emergency use license from the FDA.
The positive results obtained in the Phase 3 study of the drug played a role in the FDA's approval of the antibody drug for emergency use. Interim results of this study showed an 85 percent reduction in the risk of hospitalization or death in high-risk adult COVID-positive patients compared with placebo. In addition, laboratory data revealed that the drug is effective against all known variants, including the Indian variant. In line with the emergency use approval of the FDA, the drug is aimed to be accessible to eligible patients diagnosed with COVID-19 in the USA in the coming weeks.
The European Medicines Agency, EMA, also gave the green light to the emergency use approval of the drug.
The processes carried out with the European Medicines Agency (EMA) and other global regulatory authorities for the emergency use approval of the drug continue. The EMA Human Medicinal Products Board had recently given a positive opinion on the drug by evaluating the analysis of the efficacy and safety data obtained as a result of the "COVID-19 Monoclonal Antibody Efficacy Study" conducted in adults at high risk of hospitalization.