Regeneran asks the FDA for emergency authorization of its Covid-19 antibody therapy that was given to Trump last week.


The biotechnology company has confirmed that it submitted an application for authorization in a statement on its website on Wednesday night.

“Under our agreement with the U.S. government for the initial dose of REGN-COV2, the government is committed to making this dose available to the American people free of charge and will be responsible for their distribution, if approved by the EUA, “The statement said. . “At the moment, doses are available for about 500,000 patients, and we expect doses to be available for a total of 1,000,000 patients over the next few months.

Experimental antibody treatment of regeneron is still in large-scale clinical trials, but it is available for pathetic use, something the FDA has to approve on an individual basis, as it was for the president.

Antibody therapy is a combination of two monoclonal antibodies designed to prevent SARS-CoV-2, the virus that causes Covid-19, the company said in a statement.

Cocktail antibody therapy uses two or more lab-engineered antibodies. Regeneran’s cocktail contains a monoclonal antibody that targets spike proteins used to drill into healthy cells, and another antibody that targets different parts of the novel coronavirus. Together, the hope is to trap and close the viral replica.

Preliminary data show promising results of Regeneron's antibody cocktail for coronavirus

“When you weigh the potential benefits versus the risks, the downside is very low here because we haven’t seen any safety concerns,” Trump told CNN after receiving an 8-gram dose of treatment.

Preliminary data from the company’s antibody trials were recently released that it works fairly safely with few side effects.

“This class of drug is an extremely safe class,” Scliffer said.

D Control. Richard Besser, former executive director of the U.S. Centers for Disease Control and Prevention, who is now head of the Robert Wood Johnson Foundation, said it makes sense that treatments that give a patient antibodies would help the immune system, but he said peer review Will get.

“I will stay the verdict until we see the data,” Besser said. “You know these preliminary results that keep coming up in the press lists from companies, it tells me more about the share price of science.”

But former CDC director Dr. Thomas Frieden disagreed with Besser.

Fragen told CNN that while antibiotic treatment with regeneron is unofficial, it is “a promising treatment.”

“There is a report that less than 300 patients have received it,” he said. “It seems most effective early in the disease, especially before patients make antibodies.”

“We don’t know if it will be helpful, but it’s something that isn’t unreasonable to try,” Frieden said.

Regeneron is not the only company working on antibody therapy for coronavirus. There are at least 70 different antibody treatments for Covid-19 under investigation.

CNN’s Jane Christensen and Amanda Seeley contributed to the story.

.