© Reuters. FILE PHOTO: A GSK logo is seen at the GSK research centre in Stevenage
(Reuters) -GSK and Vir Biotechnology (NASDAQ:) have filed an application to U.S. regulators for emergency use authorization of their antibody therapy to treat early-stage COVID-19 infections, the drugmakers said on Friday.
Earlier this month, London-listed GSK and U.S.-based Vir found their experimental treatment, VIR-7831, reduced the risk of hospitalization and deaths among patients by 85%, based on interim data from a study.
The application is to treat adults and adolescents of over 12 yeas of age and weighing at least 40 kilograms that have mild-to-moderate COVID-19 and are at risk of being hospitalised due to severe illness which could also lead to death.
The United States has already recommended similar therapies from Eli Lilly (NYSE:) and Regeneron (NASDAQ:), while European health regulators are reviewing treatments from the class of medicines called monoclonal antibodies.
These monoclonal antibodies are synthetically manufactured copies of the human body’s natural infection-fighting proteins and are already being used to treat some types of cancers. Regeneron’s therapy was given to former U.S. President Donald Trump during his COVID-19 infection.
GSK and Vir said they are in discussions with the European Medicines Agency and other global regulators for approvals of their treatment, part of a wider collaboration on developing COVID-19 drugs based on monoclonal antibodies.