Regeneron applies for FDA Emergency Use Authorization for COVID-19 antibody treatment given to Trump

pharmafile | October 8, 2020 | News story | Manufacturing and Production COVID, Trump, coronavirus 

Regeneron has announced that it has applied for an Emergency Use Authorization from the FDA for its experimental antibody therapy that has been given to President Trump in his fight against coronavirus. 

The company released a statement that said: “Under our agreement with the U.S. Government for the initial doses of REGN-COV2, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.”

Their therapy is a cocktail that uses two or more lab-engineered antibodies, this includes a monoclonal antibody that targets the spike protein, which the virus uses to attach to healthy cells, while the other targets a different part of the virus. The combination is designed to shut down viral replication.

The treatment has been shown to work fairly well and safely in early trials. However, currently it is unproven, with only 300 patients having received the drug, and the data has not been peer-reviewed. 

President Trump, who is currently being treated for COVID-19, received the cocktail due to a compassionate use exemption, and said: “I wasn’t feeling so hot, and within a very short period of time, they gave me Regeneron [sic], and it was like, unbelievable. I felt good immediately. I felt as good three days ago as I do now.

“If you’re in the hospital and you’re feeling really bad, I think we’re going to work it so that you get them and you’re going to get them free, and especially if you’re a senior, we’re going to get you in there quick. We have hundreds of thousands of doses that are just about ready. I have emergency use authorization, all set, and we got to get it signed now, and you’re going to get better. You’re going to get better, really fast. These are things that nobody even thought of a few months ago. The job that the scientists, the labs, everybody has done is incredible.”

He also erroneously claimed that the cocktail wasn’t just a treatment: “It’s a cure. 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.”

In response to Trump’s claims, Dr Richard Besser, the former Director of the Centers for Disease Control and Prevention, said on Regeneron’s treatment: “I would withhold judgment on this until we see the data. You know these early results that keep coming out from companies in press releases strike me as being … much more about the stock price than they are about science.”

Eli Lilly is also making its own experimental antibody treatment for coronavirus and has also asked the FDA for an Emergency Use Authorization. The combination therapy was generally well tolerated in early trials and there were no drug-related serious adverse events.

Conor Kavanagh

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