Regeneron Asks F.D.A. for Emergency Approval for Drug That Trump Claimed Cured Him

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Regeneron Asks F.D.A. for Emergency Approval for Drug That Trump Claimed Cured Him

The drug maker Regeneron said on Wednesday night that it had filed an application with the Food and Drug Administration for emergency approval of the experimental antibody cocktail, which President Trump had praised as a "cure" for the coronavirus a few hours earlier without evidence.

The company said that access to treatment would be extremely limited at first, with only enough doses for 50,000 patients, a far cry from the "hundreds of thousands" doses Mr Trump said in a video released Wednesday that he would soon be with Americans provide free of charge.

In the five-minute video, Mr. Trump said it was a "blessing from God" that he was infected with the coronavirus and that the Regeneron cocktail made him suddenly feel better. "I felt amazing," he said. "I felt good straight away."

There's no evidence to suggest that treatment was why he felt better, and his doctors have said he took other medications as well.

"I call this a cure," Mr Trump said on the video, adding that he would make sure it was in every hospital as soon as possible.

Mr Trump gave the impression that he was the F.D.A. Approve Regeneron's treatment, though the agency's scientists are supposed to make independent decisions about approvals.

"I have an emergency permit and we have to have it signed now," said Trump.

A spokeswoman for the F.D.A. declined to comment on Wednesday as the agency fails to confirm or reject product applications.

News of Regeneron's motion on the same day that Mr. Trump extensively praised the unproven drug should heighten fears that the president is pressuring federal health officials to make decisions that are supposed to benefit him politically. In the video, Mr Trump reiterated his wish to have a vaccine approved before the election, although the vaccine manufacturers themselves have said it is highly unlikely.

Regeneron's treatment is a cocktail of two powerful antibodies that are believed to boost the immune response to the virus. The first results seem promising. In a press release, the company announced that the cocktail had lowered virus levels, especially in people who had not made their own antibodies. However, the company has not yet released detailed data to support its claim. Clinical studies are ongoing.

Medicines are generally not considered safe or effective until rigorous clinical trials are compared to compare a group of people who received treatment with those who received a placebo.

The company has received more than $ 500 million from the federal government to develop and manufacture its experimental treatment as part of Operation Warp Speed. These are federal efforts to develop viable vaccines and treatments for the virus and to spread them as they become available.

The company expects doses to be available to 300,000 patients in the next few months. As part of the agreement with the federal government, it was stipulated that these cans would be made available free of charge. In August it announced a partnership with pharmaceutical company Roche to increase production to approximately 250,000 doses per month by next year.

Mr Trump received the antibody cocktail on Friday, but it's not the only drug he's been prescribed. He has taken the antiviral drug remdesivir as well as the steroid dexamethasone, which the World Health Organization and the National Institutes of Health recommend only for people who have severe or critical cases of Covid-19.

In an interview the Wednesday before the company's announcement, Dr. George Yancopoulos, President and Chief Scientific Officer of Regeneron, said it was possible that Mr. Trump responded to the treatment and the virus levels had dropped. "That is a logical conclusion," said Dr. Yancopoulos. "Because of its symptomology, that must have happened."

But neither Dr. Yancopoulos nor Mr. Trump can definitely say whether the treatment has worked. Any number of factors could complicate the picture, including the fact that most people infected with the virus recover. Because of this, drugs are typically tested in large clinical trials involving hundreds and sometimes thousands of people.

Dr. Peter Chin-Hong, Infectious Disease Specialist at U.C.S.F. San Francisco Health, in his opinion, said there was "a million percent no" chance that Regeneron treatment could have cured Mr. Trump in 24 hours, the president claimed.

Another explanation, he said, is that the president is experiencing the effects of the steroid dexamethasone, which he has been on since Saturday, which is known to reduce fevers and create well-being and euphoria in patients. "All of this is consistent with the dexamethasone," said Dr. Chin-Hong.

Gina Kolata contributed to the coverage.

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