FDA authorizes Regeneron drug used by Trump

View of Regeron Pharmaceuticals’ corporate and research and development headquarters on Old Saw Mill River Road in Tarrytown, New York.

Lev Raidin | Lighterket | Getty Images

The Food and Drug Administration allowed an emergency use authority for Regeneron’s Kovid-19 antibody treatment, the experimental therapy President Donald Trump gave when he contracted coronavirus in October.

Regeneron submitted an emergency-use application that month after preclinical studies showing that therapy called REGN-COV2 reduced the virus and associated damage in the lungs of non-human primates. The company said test data also showed the drug reduced medical visits in patients with mild to moderate Kovid-19.

The therapy of resenarone is part of a class of therapies known as monoclonal antibodies, which are designed to act as immune cells, which scientists hope can fight infection. The monoclonal antibody treatment gained widespread attention after news that Trump received Regeron’s antibody cocktail. As Trump’s health improved, he changed it to “cure”. But the CEO of Regeneron, Drs. Leonard Sleifer has emphasized that more testing is needed.

Trump said in a video posted on Twitter on October 7, “Some people don’t know how to define a therapeutic. I look at it differently. It’s a cure.” “For me, I walked in. I didn’t feel well. 24 hours later, I felt great. I wanted to get out of the hospital. And that’s what I want for everyone. I want everyone Be given to someone. The same treatment as your President because I feel so good. “

Regeneron’s authorization comes after the FDA announced on November 9 that it had authorized Eli Lilly’s antibody treatment — called bamalanivimab — for people who are infected with Kovid and are at risk of developing a severe form of the disease. is. Officials said the treatment should not be used for hospitalized patients as it is not helpful to show the medicine at that stage of the disease.

The authority will expand the number of drugs at the disposal of doctors to fight the virus, which is spreading rapidly in the United States and other parts of the world. Prior to authorization, people could only obtain the drug as part of an FDA program that gives some patients limited access to investigational medical products. Gilead Sciences’ antiviral drug Remedisvir is the first and only fully approved treatment in the US for Kovid.

This is a developing story. Please check back for updates.

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