Trump pushes FDA to speed review of Regeneron and Eli Lilly COVID-19 treatments: report
The move comes a day after Trump's appeal to regulators in a video
President Trump and White House Chief of Staff Mark Meadows have reportedly contacted Food and Drug Administration Commissioner Stephen Hahn urging him to accelerate the agency’s review of Regeneron Pharmaceuticals' antibody cocktail, sources familiar with the situation told The Washington Post.
The Post noted that one of the anonymous administration officials said both the president and Meadows are looking to quickly "clear the bureaucracy" so they can save lives.
“You wouldn’t believe the level of bureaucracy these things get steeped in,” the official told the Post. “We have to speed these things up.”
Another unnamed senior official reportedly said that Hahn has received multiple calls in the last few days from the White House.
“The message is clear. Let’s get it done,” the official added.
According to the Post, that official added the White House is pushing for emergency clearance for both Regeneron's experimental drug and for a similar drug being developed by Eli Lilly.
A spokesperson for the FDA declined to comment while the White House did not immediately return FOX Business' request for comment.
TRUMP PUSHES REGENERON, ELI LILLY, COVID-19 TREATMENTS FOR EMERGENCY AUTHORIZATIONS
The Post report comes just a day after the President made the same appeal to regulators via a video message posted to Twitter.
Trump specifically touted Regeneron's antibody cocktail on Wednesday as being a key aspect of his treatment for the coronavirus, likening it to a "cure" rather than a therapeutic treatment.
"We have hundreds of thousands of doses that are just about ready," Trump said. "I have emergency use authorization all set and we got to get it signed now. And you’re going to get better, you’re going to get better really fast.”
In addition, Trump said on Wednesday that the administration intends to make both Regeneron and Eli Lilly's treatments free for patients suffering from the virus, especially seniors.
He also said the military will handle the logistics for the distribution of the treatments, claiming they could potentially deliver "hundreds of thousands of doses" within days.
"We’re waiting for the emergency use authorization, and the drug companies have just made a lot of it," Trump added. "So hopefully this is not going to be not just a therapeutic, its going to be much more than a therapeutic. You’re going to get better, you’re going to get better fast. Just like I did.”
JOHNSON & JOHNSON TO SUPPLY UP TO 400M DOSES OF POTENTIAL COVID-19 VACCINE TO EU
Regeneron Pharmaceuticals said in a statement on its website Wednesday that it has submitted a request for an emergency use authorization for the antibody cocktail.
"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 company 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 CEO Dr. Leonard Schleifer told Fox News about the company's plans to get an expanded emergency use authorization earlier this week.
"I don’t know how long that will take," he added. "We are working with the FDA, we think we meet the criteria.”
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Eli Lilly had also submitted its own emergency use authorization request Wednesday for its LY-CoV555 monotherapy. The company said it anticipates it could supply as many as 100,000 doses by the end of October, and up to 1 million by next year.
"We expect to submit a subsequent request for EUA for combination therapy in November, pending clinical trial enrollment, once additional safety data accumulate and sufficient supply is manufactured," the company added. "Lilly anticipates having data to support a biologics license application submission for combination therapy as early as [the second quarter of] 2021. Conversations with global regulators are ongoing."
Both drugs are currently being tested in clinical trials to determine their effectiveness against the virus.
|REGN||REGENERON PHARMACEUTICALS INC.||739.95||+8.78||+1.20%|
|LLY||ELI LILLY & CO.||442.33||+5.84||+1.34%|
The push for the antibody treatments come as the window of opportunity for an approved coronavirus vaccine before Election Day is rapidly closing. According to the latest update by Johns Hopkins University, there are more than 7.5 million confirmed coronavirus cases in the United States and more than 212,000 related deaths.
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This story has been updated to include the FDA's response to FOX Business' request for comment