(Reuters) –GSK and Vir Biotechnology 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 and Regeneron, 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.
Reporting by Pushkala Aripaka in Bengaluru and Ludwig Burger in Frankfurt; Editing by Arun Koyyur and Krishna Chandra Eluri