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 issued emergency approval for treatment with Regeneron's Covid-19 antibodies, the experimental therapy given to President Donald Trump when he contracted the coronavirus in October.
Regeneron filed an emergency application earlier this month after preclinical studies showed that therapy called REGN-COV2 reduced virus levels 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 relieve 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 needed.
"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 walked 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 because I feel great. "
Regeneron's approval comes after the FDA announced on Nov. 9 that it approved Eli Lilly's antibody treatment – called bamlanivimab – for people newly infected with Covid who are at risk of developing a severe form of the disease develop. 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. Prior to approval, people could only get the drug through an FDA program that gave some patients limited access to investigational medicinal products. Gilead Sciences' antiviral drug Remdesivir is the first and only fully approved treatment for Covid in the United States.