Regeneron asks for emergency FDA approval for COVID-19 antibody treatment

Oct. 8 (UPI) — Biotechnology company Regeneron has requested emergency use authorization from federal regulators for a COVID-19 antibody treatment.

The REGN-COV2 treatment is a combination of two antibodies that’s designed to “block infectivity” of the SARS-CoV-2 virus that causes COVID-19.

“The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population,” the company said in a statement.

Regeneron, which asked the Food and Drug Administration for the emergency authorization, said it has doses available for 50,000 patients and will have enough for another 300,000 in the coming months.

“If [emergency use authorization] 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,” the company added.

President Donald Trump took a dose of the Regeneron cocktail last week after he tested positive for COVID-19, even though it hasn’t been approved by the FDA.

Regeneron said if its request is approved, it will distribute the treatment in the United States and partner Roche will distribute overseas.

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DC health dept asks WH attendees to get tested

WASHINGTON — The Washington D.C. Department of Health has released an open letter appealing to all White House staff and those attending a Sept. 26 event in the Rose Garden to seek medical advice and take a coronavirus test.

The letter indicates a lack of confidence in the White House medical team’s contact tracing efforts for the virus outbreak that infected President Donald Trump, multiple senior staff members and two U.S. senators, among others.

Co-signed by nine other local health departments from neighboring jurisdictions in Maryland and Virginia, the letter says contact tracing on the outbreak has been insufficient and “there may be other staff and residents at risk for exposure to COVID positive individuals.”


The move highlights the public health dilemma faced by Mayor Muriel Bowser’s administration regarding the current outbreak. The Trump White House has operated for months in open violation of several D.C. virus regulations, hosting multiple gatherings that exceeded the local 50-person limit and where many participants didn’t wear masks.

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HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— Washington DC health department asks Rose Garden attendees to get tested

— Paris hospitals on emergency footing as ICUs fill with coronavirus patients

— Am I immune to the coronavirus if I’ve already had it?

— President Trump says he’s ready to hold campaign rallies, credits an experimental drug treatment with helping recovery from COVID-19.

— Coronavirus infections in Ukraine began surging in late summer, hospitals are ‘catastrophically short of doctors.’

— The NFL’s Tennessee Titans had another positive test, bringing the team’s outbreak of COVID-19 to 23.

— Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

TRENTON, N.J. — New Jersey added 1,300 new coronavirus cases overnight, the highest level since late May.

Health Commissioner Judy Persichilli says most of the positive cases in Ocean County stem from Lakewood, predominantly among white men ages 19-49 and could be related to religious services or celebrations that occurred in late September.

Hospitalizations also increased to 652, the highest level since early August.

Eleven more people died in the last day, bringing the statewide confirmed total to 14,373. The positivity rate for testing stood at 3.69%, while the rate of transmission fell to 1.22, down from 1.27.

The state has stockpiled personal protective equipment, ventilators and the therapeutic drug Remdesivir, Persichilli says.

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MADRID — Spain’s health ministry is reporting 12,423 new coronavirus cases and 126 confirmed deaths Thursday, the day a court struck down a partial lockdown in hard-hit Madrid.

With 848,324 infections since the start of the pandemic, Spain has the highest caseload in Europe. The official death toll rose to 32,688, although limits on testing early in the year means the actual number of victims is likely much higher.

The country’s 14-day rate of 256 new cases per 100,000 inhabitants varies greatly from region to region, with Madrid’s 563 topping the charts. That’s five times the European average rate as of Sept. 27, according to data of

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

Regeneron says it has applied to the US Food and Drug Administration for emergency use authorization for its experimental monoclonal antibody therapy, the same antibody cocktail given to President Donald Trump Friday after he was diagnosed with the virus.



a woman preparing food in a kitchen: New York state based biotech company, Regeneron is working on an antibody therapy to treat, and possibly prevent, Covid-19.


© Regeneron
New York state based biotech company, Regeneron is working on an antibody therapy to treat, and possibly prevent, Covid-19.

The biotechnology company confirmed it had submitted the application for the authorization in a statement on its website Wednesday night.

“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,” the statement said. “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.

Regeneron’s experimental antibody treatment is still in large-scale clinical trials, but has been available for compassionate use, something the FDA has to approve on an individual basis, like it did for the President.

The antibody therapy is a combination of two monoclonal antibodies that is designed specifically to block infectivity of SARS-CoV-2, the virus that causes Covid-19, according to the company’s statement.

A cocktail antibody therapy uses two or more lab-engineered antibodies. Regeneron’s cocktail includes a monoclonal antibody that targets the spike protein the virus uses to drill into healthy cells, and another antibody that targets a different part of the novel coronavirus. With two, the hope is to trap and shut down viral replication.

“When you weigh the potential benefit versus the risks, the downsides are very low here because we have not seen any safety concerns,” Regeneron CEO Dr. Leonard Schleifer told CNN in an interview after Trump received an 8 gram dose of the treatment.

Early data from the company’s antibody trials released recently showed it worked fairly safely with few side effects.

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

Dr. Richard Besser, a 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 immune system, but he said peer review will find any holes or pitfalls.

“I would withhold judgment on this until we see the data,” Besser said. “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.”

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’s a report that only fewer than 300 patients have received it,” he said. “It seems to be most effective early in the disease, especially before patients make antibodies of their own.”

“We don’t know if it’ll be helpful,

Infectious disease icon asks CDC director to expose White House, orchestrate his own firing

A former director of the Centers for Disease Control and Prevention and public health titan who led the eradication of smallpox asked the embattled, current CDC leader to expose the failed U.S. response to the new coronavirus, calling on him to orchestrate his own firing to protest White House interference.

Trump contradicted CDC director’s testimony to the Senate about importance of face masks

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Dr. William Foege, a renowned epidemiologist who served under Democratic and Republican presidents, detailed in a private letter he sent last month to CDC director Dr. Robert Redfield his alarm over how the agency has fallen in stature while the pandemic raged across America.

Foege, who has not previously been a vocal critic of the agency’s handling of the novel coronavirus, called on Redfield to openly address the White House’s meddling in the agency’s efforts to manage the COVID-19 crisis and then accept the political sacrifice that would follow. He recommended that Redfield commit to writing the administration’s failures — and his own — so there was a record that could not be dismissed.



Robert R. Redfield wearing a suit and tie: In this Sept. 16, 2020, file photo Centers for Disease Control and Prevention Director Dr. Robert Redfield appears at a Senate Appropriations subcommittee hearing on a "Review of Coronavirus Response Efforts" on Capitol Hill in Washington.


© Andrew Harnik, AP
In this Sept. 16, 2020, file photo Centers for Disease Control and Prevention Director Dr. Robert Redfield appears at a Senate Appropriations subcommittee hearing on a “Review of Coronavirus Response Efforts” on Capitol Hill in Washington.

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“You could upfront, acknowledge the tragedy of responding poorly, apologize for what has happened and your role in acquiescing,” Foege wrote to Redfield. He added that simply resigning without coming clean would be insufficient. “Don’t shy away from the fact this has been an unacceptable toll on our country. It is a slaughter and not just a political dispute.”

The CDC did not immediately respond to a request for Redfield’s response. Redfield, an HIV/AIDS expert and former military physician, lacked experience running a public health agency when Trump selected him to head the CDC in 2018.

White House spokesman Judd Deere did not respond to the contents of the letter but said in a statement that the CDC has not been compromised. “This dishonest narrative that the media and Democrats have created that politics is influencing decisions is not only false but is a danger to the American public,” Deere said.

MORE: How the CDC failed public health officials fighting the coronavirus

Foege’s Sept. 23 letter, which was obtained by USA TODAY and has not been previously reported, is a striking condemnation from a legendary public health figure who has spent decades helping prevent the spread of diseases while earning the respect of peers.

In an interview, Foege said he felt compelled to write to Redfield after the White House appointed Dr. Scott Atlas to the coronavirus task force, even though he is not an infectious disease expert.

The Washington Post and other outlets have reported that Atlas has endorsed the controversial strategy of herd immunity, although Atlas has denied doing so.