View of the Regeneron Pharmaceuticals headquarters on Old Saw Mill River Road in Tarrytown, New York.
Lev Radin | LightRocket | Getty Images
The Food and Drug Administration on Saturday granted emergency use Authorization for Regeneron‘s Covid-19 Antibody treatment, the experimental therapy given to the President Donald Trump when he became infected with the coronavirus in October.
Regeneron filed an emergency application This month after preclinical studies, the therapy called REGN-COV2 was shown to reduce the amount of virus and associated lung damage in non-human primates. The company said study data also show the drug reduced the number of doctor visits for patients with mild to moderate Covid-19.
“The FDA remains committed to improving the country’s public health during this unprecedented pandemic. Approval of these monoclonal antibody therapies can help outpatients avoid hospital stays and reduce the burden on our healthcare system.” said FDA Commissioner Stephen M. Hahn.
Regeneron’s therapy is part of a class of treatments known as monoclonal antibodies, which act as immune cells that scientists hope can fight infections. Monoclonal antibody treatments gained widespread attention after it was revealed that Trump had received Regeneron’s antibody cocktail. As Trump’s health improved he touted it as a “cure”. Regeneron’s CEO Dr. Leonard Schleifer, however, has emphasized that further testing is required.
“Some people don’t know how to define therapeutics. I see it differently. It’s a cure,” Trump said in a video posted on Twitter on October 7th. “I came in for me. I didn’t feel good. A short 24 hours later I felt great. I wanted out of the hospital. And I want that for everyone. I want everyone to get this.” same treatment as your president for feeling great. “
Regeneron’s authorization takes place after The FDA announced on November 9th that Eli Lilly’s antibody treatment – called bamlanivimab – approved it for people who have been newly infected with Covid and are at risk of developing a severe form of the disease. Officials said the treatment should not be used for hospitalized patients as there is no data to show the drug is helpful at this stage of the disease.
The approval will increase the number of drugs available to doctors to fight the virus, which continues to spread rapidly in the United States and other parts of the world. Before approval, people could only get the drug as part of an FDA program This gives some patients limited access to investigational drugs. Gilead Sciences‘The antiviral drug Remdesivir is the first and only fully approved treatment for Covid in the United States.