View of Corporate and Research and Development Headquarters of Regeneron Pharmaceuticals on Old Saw Mill River Road in Tarrytown, New York.
Lev Radin | LightRocket | Getty Images
The Food and Drug Administration on Saturday granted an emergency use authorization for Regeneron‘s Covid-19 antibody treatment, the experimental therapy given to President Donald Trump when he contracted the coronavirus in October.
Regeneron submitted an emergency use application that month after preclinical studies showed that the therapy, called REGN-COV2, reduced the amount of virus and associated damage in the lungs of non-human primates. The company said trial data also shows the drug reduces medical visits in patients with mild-to-moderate Covid-19.
“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said FDA Commissioner Stephen M. Hahn. “As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments.”
Regeneron’s therapy is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells that scientists hope can fight infections. Monoclonal antibody treatments gained widespread attention after news that Trump received Regeneron’s antibody cocktail. As Trump’s health improved, he touted it as a “cure.” But Regeneron’s CEO, Dr. Leonard Schleifer, has stressed that more testing is required.
“Some people don’t know how to define therapeutic. I view it different. It’s a cure,” Trump said in a video posted Oct. 7 on Twitter. “For me, I walked in. I didn’t feel good. A short 24 hours later, I was feeling great. I wanted to get out of the hospital. And that’s what I want for everybody. I want everybody to be given the same treatment as your president because I feel great.”
Regeneron’s authorization comes after the FDA announced on Nov. 9 that it had authorized Eli Lilly’s antibody treatment – called bamlanivimab –for people newly infected with Covid and are at risk of developing a severe form of the disease. Officials said the treatment shouldn’t be used for hospitalized patients because there is no data to show the drug is helpful at that stage of the disease.
The authorization will expand the number of drugs at doctors’ disposal to fight the virus, which continues to rapidly spread across the United States and other parts of the world. Before the authorization, people could only get the drug as part of an FDA program that gives some patients limited access to investigational medical products. Gilead Sciences‘ antiviral drug remdesivir is the first and only fully approved treatment in the U.S. for Covid.