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Regeneron asks F.D.A. for emergency approval for the drug that Trump claimed cured him



Drug manufacturer Regeneron said Wednesday night which had submitted an application to the Food and Drug Administration for emergency approval of the experimental antibody cocktail that President Trump had praised a few hours earlier without evidence as a “cure” for the coronavirus.

The company said 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” of doses that Mr. Trump said in a video posted Wednesday that it would soon be state. made available to Americans 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 had suddenly made him feel better. “I felt incredible,” he said. “I felt good immediately.”

There is no evidence that the treatment is why she felt better, and her doctors said she took other medications as well.

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

Mr. Trump gave the impression that he was going to push the F.D.A. to approve Regeneron’s treatment, although the agency’s scientists would have to make independent decisions on approvals.

“I have all the permissions for emergency use and we need to get it signed now,” Trump said.

A spokesperson for the F.D.A. declined to comment on Wednesday, saying the agency does not confirm or deny product applications.

News of Regeneron’s question on the same day Trump effusively praised the unproven drug is likely to intensify fears that the president is lobbying federal health agencies to make decisions aimed at politically benefiting him. In the video, Mr. Trump reiterated his desire to get a vaccine approved before the election, even though the vaccine manufacturers themselves said it was highly unlikely.

Regeneron treatment is a cocktail of two powerful antibodies that are believed to increase the immune response to the virus. The first results look promising. In a press release, the company said the cocktail lowered virus levels particularly in people who hadn’t made their own antibodies, but the company has not yet released detailed data to support its claim. Clinical trials are not yet complete.

The drugs are generally not considered safe or effective until they undergo rigorous clinical trials that 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, the federal effort to find viable vaccines and treatments for the virus and to help distribute them once they become available.

The company said it plans to have doses available for 300,000 patients in the coming months. Under the agreement with the federal government, he said those doses would be made available for free. In August, it announced a partnership with pharmaceutical company Roche to increase production to around 250,000 doses per month within the next year.

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

In an interview Wednesday prior to the company’s announcement, Dr. George Yancopoulos, president and chief scientific officer of Regeneron, said it was possible that Mr. Trump had responded to the treatment and that the virus level had decreased. “This is a logical conclusion,” said Dr. Yancopoulos. “Based on his symptoms, it must have happened.”

But neither Dr. Yancopoulos nor Mr. Trump can say for sure if the treatment worked. Any number of factors could complicate the picture, including the fact that most people infected with the virus recover. That is why drugs are typically tested in large clinical trials with hundreds and sometimes thousands of people.

Dr. Peter Chin-Hong, an infectious disease specialist at U.C.S.F. Healthcare in San Francisco said in its opinion, there was “a million percent no” chance that the Regeneron treatment could cure Mr. Trump in 24 hours, as the president claimed.

Another explanation, he said, is that the president is experiencing the effects of the steroid dexamethasone, which he has been receiving since Saturday, which is known to reduce fever and can create feelings of well-being and euphoria in patients. “This is all in harmony with the speaking dexamethasone,” said Dr. Chin-Hong.

Gina Kolata contributed to the report.


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