Emergency Use Authorization Granted for COVID-19 Drug Developed by GSK and Vir Biotechnology

The US Food and Drug Administration (FDA) has granted emergency use authorization for a monoclonal antibody drug developed by GSK and Vir Biotechnology for early treatment of coronavirus patients. The FDA has granted emergency use authorization for a monoclonal antibody drug developed by GSK and Vir Biotechnology for early treatment of COVID-19 patients at risk of developing severe complications. The FDA's emergency authorization of the antibody drug was supported by positive results obtained in Phase 3 studies of the medication. According to interim results of this study, an 85% reduction in hospitalization or death risk was observed in high-risk adult COVID-positive patients compared with placebo. Laboratory data also demonstrated that the drug is effective against all known variants, including the Indian variant. In line with the FDA's emergency use authorization, the drug is aimed to be accessible in the coming weeks for eligible COVID-19 diagnosed patients in the United States.  

European Medicines Agency EMA also gave the green light for emergency use authorization of the drug

Processes conducted with other global regulatory authorities, particularly the European Medicines Agency (EMA), for emergency use authorization of the drug are ongoing. The EMA Committee for Medicinal Products for Human Use recently issued a positive opinion on the drug after evaluating the efficacy and safety data obtained from the "COVID-19 Monoclonal Antibody Efficacy Study" conducted in high-risk hospitalized adults.