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Home / Tips and Tricks / Regeneron is asking the FDA for emergency approval for the Covid-19 antibody therapy that Trump was given last week

Regeneron is asking the FDA for emergency approval for the Covid-19 antibody therapy that Trump was given last week



The biotechnology company confirmed that it filed the application for approval in a statement on its website on Wednesday evening.

“Under our agreement with the US government for the initial doses of REGN-COV2, the government is committed to providing those doses to the American people free of charge if an EUA is granted and would be responsible for distributing them,” it said in the statement. “There are currently doses available for approximately 50,000 patients and we expect a total of 300,000 patient doses to be available over the next several months.

Regeneron’s experimental antibody treatment is still in large clinical trials but has been available for compassionate use, which the FDA, like the President, must approve individually.

Antibody therapy is a combination of two monoclonal antibodies specifically designed to block the infectivity of SARS-CoV-2, the virus that causes Covid-1

9, the company said.

Cocktail antibody therapy uses two or more laboratory-made antibodies. Regeneron’s cocktail contains a monoclonal antibody that targets the spike protein that the virus uses to dig into healthy cells and another antibody that targets a different part of the new coronavirus. With two, the hope is to intercept and turn off virus replication.

Early data shows promising results from Regeneron's antibody cocktail against coronavirus

“When you weigh the potential benefits against the risks, the downside here is very small as we didn’t see any safety concerns,” said Dr. Leonard Schleifer, CEO of Regeneron, told CNN in an interview after Trump received an 8-gram dose of the treatment.

Early data from the company’s recently published antibody studies showed that it works fairly safely with few side effects.

“This class of drugs is an extremely safe class,” said Schleifer.

Dr. Richard Besser, a former acting director of the U.S. Centers for Disease Control and Prevention who now heads the Robert Wood Johnson Foundation, said it made sense that treatment with patient antibodies would help the immune system, but said it will be peer reviewed find no holes or pitfalls.

“I would withhold the verdict until we see the data,” said Besser. “You know these early results, which companies keep getting published in press releases, to me … speak a lot more about stock price than science.”

But Dr. Thomas Frieden, also a former CDC director, disagreed with Besser.

Although Regeneron’s antibody therapy has not been proven, it is “a promising treatment,” Frieden told CNN.

“There is one report that fewer than 300 patients received it,” he said. “It seems to be most effective early in the disease, especially before patients make their own antibodies.”

“We don’t know if it will help, but it is not inappropriate to try,” said Frieden.

Regeneron isn’t the only company working on antibody therapies for the coronavirus. At least 70 different antibody treatments for Covid-19 are being studied.

CNN’s Jen Christensen and Amanda Sealy contributed to this story.


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