View of Regeneron Pharmaceuticals corporate and research and development 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 President Donald Trump when he contracted the coronavirus in October.
Regeneron submitted an emergency use request this month after preclinical studies showed the therapy, called REGN-COV2, reduced the amount of virus and associated damage in the lungs of non-human primates. The company said data from the trials also shows the drug is reducing medical visits in patients with mild to moderate Covid-19.
“The FDA remains committed to advancing the country’s public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help ambulatory patients avoid hospitalization and ease the burden on our healthcare system,” said FDA Commissioner Stephen M. Hahn.
Regeneron therapy is one of a class of treatments known as monoclonal antibodies, which are designed to act like immune cells that scientists hope can fight infection. Monoclonal antibody treatments have drawn widespread attention after news that Trump had received the antibody cocktail from Regeneron. As Trump’s health improved, he touted it as a “cure.” But Regeneron CEO Dr Leonard Schleifer stressed that more testing was needed.
“Some people don’t know how to define therapy. I see it differently. It’s a cure,” Trump said in a video posted Oct. 7 on Twitter. “For me, I entered. I did not feel well. Barely 24 hours later, I was feeling good. I wanted to get out of the hospital. And that’s what I want for everyone. I want everyone to receive the same treatment as your president because I feel good. “
Regeneron’s clearance comes after the FDA announced on November 9 that it had cleared Eli Lilly’s antibody treatment – called bamlanivimab – for people newly infected with Covid and at risk of developing a severe form of the disease. Officials said the treatment should not be used in hospital patients because there is no data showing the drug is helpful at this stage of the disease.
The authorization 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 authorization, people could only get the drug through 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 United States for Covid.