The US Foods and Drug Administration has granted emergency approval for Regeneron’s synthetic antibody treatment against COVID-19, which has been specifically used to treat US President Donald Trump.
“Allowing outpatient treatments with monoclonal antibodies may help outpatients avoid hospitalization and reduce the burden on our healthcare system,” said Stephen Hahn, commissioner for the FDA, in a statement.
Regeneron applied to allow its drug to be used in emergency situations in October after preclinical studies showed the treatment reduced the amount of the virus and the associated damage in the lungs of non-human primates.
Regeneron is part of a class of treatments known as monoclonal antibodies, which are manufactured to function as immune cells that scientists hope will be effective in fighting infections.
Regeneron’s licensing comes after the U.S. Food and Drug Administration announced on November 9 that it had allowed Eli Lilly to deal with an antibody – called mlanivimab – for people newly infected with the COVID-19 virus are at risk of contracting a severe form of the disease. The treatment should not be used for hospitalized patients, officials said, as there is no data showing the drug is useful at this stage of the disease.
The approval will increase the number of drugs doctors have at their disposal to combat the virus, which continues to spread rapidly throughout the United States and other parts of the world.
And last month, US President Donald Trump said he is seeking to get rapid approval of antibody drugs produced by “Regeneron” and “Eli Lilly” companies, and to put them in hospitals, after his personal experience in treatment with them following his infection with the Coronavirus.