View of Regeneron Pharmaceuticals Company and Research and Development Headquarters at Old Saw Mill River Road in Tarrytown, New York.
Lev Radin | LightRocket | Getty Images
The Food and Drug Administration on Saturday granted an emergency permit for Regeneron’s Covid-19 antibody treatment, the experimental therapy given to President Donald Trump when he contracted coronavirus in October.
Regeneron submitted an emergency application that month after preclinical studies showed that the treatment, called REGN-COV2, reduced the amount of virus and associated damage to the lungs of non-human primates. The company said experimental data also show that the drug reduces medical visits in patients with mild to moderate Covid-1
“The FDA remains committed to promoting the nation’s public health during this unprecedented pandemic. Approval of these monoclonal antibody therapies can help outpatients avoid hospitalization and alleviate the burden on our health care system,” said FDA Commissioner Stephen M. Hahn.
Regeneron’s treatment is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells that researchers hope can fight infections. Monoclonal antibody treatments received widespread attention following the news that Trump received Regeneron’s antibody cocktail. As Trump’s health improved, he called it a “cure.” But Regeneron’s CEO, Dr. Leonard Schleifer, has stressed that more tests are required.
“Some people do not know how to define therapeutically. I see it differently. It’s a cure,” Trump said in a video posted Oct. 7 on Twitter. “For me I went in. I did not feel well. Short 24 hours later I felt good. I wanted to get out of the hospital. And that’s what I want for everyone. I want everyone to get the same treatment as your president because I’m fine. “
Regeneron’s approval comes after the FDA announced on November 9 that it had approved Eli Lilly’s antibody treatment – called bamlanivimab – for people who have recently been infected with Covid and are at risk of developing a serious form of the disease. Officials said the treatment should not be used in inpatients because there is no data showing that the drug is useful at the time of the disease.
The permit will expand the number of drugs available to doctors to fight the virus, which continues to spread rapidly across the United States and other parts of the world. Prior to approval, people could only get the drug as part of an FDA program that gives some patients limited access to medical examination products. Gilead Sciences’ antiviral drug remdesivir is the first and only fully approved treatment in the United States for Covid.