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Maker of Antibody Cocktail Trump Took Seeks Emergency Use OK | Health News

By Robin Foster and E.J. Mundell
HealthDay Reporters

(HealthDay)

THURSDAY, Oct. 8, 2020 (HealthDay News) — Regeneron Pharmaceuticals Inc. said Wednesday that it is seeking emergency approval from the U.S. Food and Drug Administration for an experimental antibody cocktail given to President Donald Trump shortly after he was diagnosed with COVID-19.

Hours before the company made the announcement, Trump proclaimed in a video released by the White House that the drug had an “unbelievable” effect on his recovery from coronavirus infection, the Washington Post reported.

“I think this was the key,” Trump said, after acknowledging that the antibody cocktail was one of several drugs he was prescribed by his medical team. While there is no hard evidence yet proving the drug’s effectiveness in humans, it has shown promise in treating mild cases of the new coronavirus, the Post reported.

In his video, Trump said, “I have emergency-use authorization all set, and we’ve got to get it signed now.” However, an FDA spokeswoman told The New York Times Wednesday that the agency does not confirm or deny product applications.

Regeneron said in its statement that it could initially produce doses of the antibody cocktail for 50,000 patients, and then ramp production up to doses for 300,000 patients in the next few months if granted emergency authorization.

The antibody cocktail is now in late-stage testing. The company has granted fewer than 10 “compassionate use” requests allowing people not enrolled in its trials to use the drug, the Associated Press reported.

The U.S. government first inked a contract with Regeneron back in July, and has promised to distribute initial doses of the treatment at no cost if it is approved, the Post reported.

Regeneron isn’t the only company developing an antibody cocktail to battle COVID-19 infection: Eli Lilly and Co. announced earlier on Wednesday that it was seeking emergency-use authorization from the FDA for a similar cocktail. Both treatments use lab-made antibodies to give patients’ immune systems a boost. In both cases, scaling up production to meet demand is expected to be a major challenge, the Post reported.

White House approves tougher vaccine development rules

Following weeks of delay, the White House on Tuesday approved tough new rules for coronavirus vaccine developers that will make it unlikely that a vaccine will be approved before Election Day.

The approval came only after the U.S. Food and Drug Administration published the updated guidelines on its website as part of briefing materials for outside vaccine advisers, the Post reported.

The standards, which would be applied to an emergency-use authorization for a vaccine, are similar to the standards for a traditional approval. But the White House has worried that the criteria would delay authorization of a vaccine beyond Nov. 3 and sat on the guidance, the Post reported.

The delayed clearance by the White House came only after White House Chief of Staff Mark Meadows demanded detailed justification from the agency about the tougher criteria, the Post reported. The FDA provided the White House with additional data,

President Trump’s COVID-19 treatment includes an experimental antibody cocktail

After confirming early on Friday morning that President Donald Trump tested positive for SARS-CoV-2, White House physicians have sent mixed messages about the leader’s condition. Trump’s lead physician Sean Conley stated in a press conference on Saturday that the president had been sick for 72 hours, which would mean he’d attended several events after receiving a diagnosis on Wednesday morning. The White House has since said this is not the case, but reports remain confusing. While Chief of Staff Mark Meadows said on Saturday that the commander-in-chief’s vital signs were “very concerning,” tweets from President Trump and those close to him maintained that he was feeling well and reviewing documents from Walter Reed National Military Medical Center in Maryland.



a close up of a glass door: The president is being treated with two drugs whose efficacy against the coronavirus is unclear.


© Provided by Popular Science
The president is being treated with two drugs whose efficacy against the coronavirus is unclear.

While we may not know for sure how the president is faring, we do know some of his treatment protocol. According to Conley, he’s received a single dose of an experimental antibody treatment from Regeneron Pharmaceuticals, as well as a multi-day course of the antiviral medication remdesivir.

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Remdesivir is a drug owned by the US pharmaceutical company Gilead, originally designed to combat Ebola. It’s an antiviral, and works not by killing the virus directly, but by inhibiting its development and replication. While remdesivir stands out as a particularly promising treatment among other potential therapies for COVID-19, its actual level of efficacy is still being determined. When speculating on possible treatments for President Trump with reporters from STAT, several clinicians noted that remdesivir would be a likely and reasonable choice if the president displayed symptoms. The National Institute of Health currently recommends that remdesivir only be administered to patients sick enough to require supplemental oxygen, which the White House has said isn’t the case for the commander-in-chief.



a close up of a glass door: One of the president's treatments is quite controversial.


© unsplash
One of the president’s treatments is quite controversial.

President Trump’s other therapy is much more controversial. Regeneron’s product REGN-COV2, which is a combination of two antibodies designed to fight against the virus that causes COVID-19, has not yet received approval or authorization from the Food and Drug Administration. The president received the drug directly from Regeneron Pharmaceuticals—companies are allowed to give out unapproved drugs at their own discretion. The first data on Regeneron’s efficacy in lowering viral spread within the body was just released on Tuesday, and is based on a late-stage clinical trial of just 275 patients.

President Trump’s COVID-19 diagnosis comes amid a slew of positive test results among prominent members of the Republican party, leading epidemiologists to suggest that a White House event on September 26 may have aided the novel coronavirus’s spread. While the main event took place in the Rose Garden—an outdoor venue, which experts say is the safest way for crowds to gather without risking exposure—smaller groups also convened inside the White House. Most attendees did not wear masks in either setting. Gathering indoors without protective masks puts individuals at very high risk of