Regeneron asks FDA for emergency clearance for its Covid-19 antibody treatment that was given to Trump last week


The biotechnology company confirmed having filed the request for authorization in a press release published Wednesday evening on its website.

“As part of our agreement with the US government for 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. », Indicates the press release. . “Currently, doses are available for approximately 50,000 patients and we expect to have doses for a total of 300,000 patients in the coming months.

Regeneron’s investigational antibody treatment is still in large-scale clinical trials, but has been available for compassionate use, which the FDA must approve on an individual basis, as it did for the president.

Antibody therapy is a combination of two monoclonal antibodies specially designed to block the infectivity of SARS-CoV-2, the virus that causes Covid-19, according to the company statement.

Cocktail antibody therapy uses two or more antibodies designed in the lab. The Regeneron cocktail consists of a monoclonal antibody that targets the spike protein that the virus uses to drill into healthy cells, and another antibody that targets a different part of the new coronavirus. With two, the hope is to trap and stop viral replication.

“When you weigh the potential benefits against the risks, the downsides are very low here because we didn’t see any safety issues,” Regeneron CEO Dr Leonard Schleifer told CNN in an interview after Trump received a dose of 8 grams of the treatment.

Early data from the company’s recently published antibody tests showed it to work fairly safely with few side effects.

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

Dr Richard Besser, former acting director of the US Centers for Disease Control and Prevention who now heads the Robert Wood Johnson Foundation, said it makes sense that a treatment that gives a patient antibodies would help the system immune, but he said peer review will find holes or pitfalls.

“I would withhold any judgment on this until we see the data,” Besser said. “You know that these first results that keep coming out of companies in press releases seem to me… much more on stock prices than on science. ”

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

Although Regeneron’s antibody therapy is unproven, it is “a promising treatment,” Frieden told CNN.

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

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

Regeneron isn’t the only company working on antibody therapies for the coronavirus. There are at least 70 different antibody treatments for Covid-19 under investigation.

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


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