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- Regeneron has submitted a request to the Food and Drug Administration (FDA) for emergency use authorization of its COVID-19 antibody treatment.
- It announced the move hours after President Donald Trump prematurely claimed the drug had cured his coronavirus in a Twitter video.
- In the video, Trump called on the FDA to approve the drug, and said the treatment should be available for free.
- There is no evidence that Regeneron’s antibody treatment improved his condition, and his doctors have said he took other drugs too.
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Regeneron said it was seeking emergency approval for its experimental COVID-19 antibody treatment — hours after President Donald Trump prematurely said the drug had cured his coronavirus.
The company said Wednesday evening it had submitted a request to Food and Drug Administration (FDA) for emergency authorization of the drug, REGN-COV2, which was one of the drugs Trump received after he was admitted to hospital with COVID-19.
In a video posted to Twitter on Wednesday, Trump claimed Regeneron’s treatment had cured him.
He also incorrectly claimed he had already authorized the drug for emergency use, adding that patients should in future get it for free.
Trump received other treatments in hospital, and there is no evidence that Regeneron’s treatment caused him to recover.
"They gave me Regeneron — other things, too — but I think this was the key," he said, adding that he "felt good immediately" after the treatment.
"They call them therapeutic, but to me it wasn't just therapeutic, it made me better. I call that a cure," he said.
"We're trying to get them on an emergency basis. We've authorized it. I've authorized it," Trump said.
—Donald J. Trump (@realDonaldTrump) October 7, 2020
Regeneron, which does not claim its treatment is a cure, said in its statement that 50,000 people would have access to the drug if it was granted approval.
The drug company expected to have enough doses available for 300,000 people in the next few months, it said.
Preliminary results from a trial show that the treatment could lower the severity of the virus in non-hospitalized patients with COVID-19.
Shares in Regeneron jumped 3.5% in late trading in New York after Trump posted the five-minute video.
Questions have been raised about Trump's ties to Regeneron. According to a financial disclosure report released in June 2017, the president has owned shares in the company. Regeneron's CEO Dr Leonard Schleifer has also been a member at Trump's golf club in Westchester, New York.
The Trump administration gave the drug maker $450 million in July as part of Operation Warp Speed, a plan to quickly develop a vaccine for COVID-19.
Eli Lilly, a drugmaker working on another antibody therapy, said on Wednesday that it was seeking an emergency FDA authorization for its treatment after promising early results.
Trump on Tuesday accused the FDA of launching a "political hit job" on him after its new, stricter guidelines for COVID-19 vaccines were approved by the White House.