The drugmaker told Regener on Wednesday evening That he applied to the Food and Drug Administration for emergency approval of an experimental antibody cocktail that President Trump praised just hours before without evidence as a “cure” for the coronavirus.
The company said that, previously, access to treatment would be extremely limited, with adequate doses for just 50,000 patients, much to the chagrin of “thousands of trusted” doses, which Mr. Trump said in a video released Wednesday that would come soon. Make it available to Americans for free.
In the five-minute video, Mr. Trump said it was “God’s blessing” that he was infected with the coronavirus and that the regenerative cocktail suddenly made him feel better. “I felt unbelievable,” he said. “I felt better right away.”
There is no evidence that the treatment is the only reason he felt better, and his doctors say he has taken other medications as well.
Mr Trump said in the video, “I call it a cure,” adding that he would make sure he was in every hospital as soon as possible.
Mr. Trump gave the impression that even though the agency’s scientists would make independent decisions about approvals, they would push the FDA to approve Regeneron’s treatment.
Mr. Trump said, “I have all the preparations for emergency use, and now we’re going to get it signed.”
An FDA spokesman declined to comment Wednesday, saying the agency does not confirm or deny production requests.
On the same day there is news of Regeneran’s plea that Mr. Trump has praised the motivation of the irrelevant drug as these fears are likely to intensify that the president is forcing federal health agencies to make decisions for the purpose of political gain. In the video, Mr. Trump reiterated his desire to have the vaccine validated before the election, even though vaccine manufacturers themselves have said it is highly unlikely.
Regeneran’s treatment is a cocktail of two powerful antibodies that are thought to stimulate the immune response of the virus. Preliminary results look promising. In a press release, the company said the cocktail reduced the amount of the virus, especially in people who did not make their own antibodies, but the company has not yet released detailed data to support its claim. Clinical trials are not yet complete.
Drugs are generally not considered safe or effective unless they undergo rigorous medical tests, which compare to a group of people who receive a placebo with treated people.
The company has received more than 500 500 million from the federal government to develop and manufacture its experimental treatment as part of Operation Worm Speed, a federal effort to come up with viable vaccines and treatments for the virus and help distribute them when they become available.
The company said it expects doses to be available to 300,000 patients in the next few months. Under an agreement with the federal government, it said the dose would be made available free of charge. In August, it announced a partnership with the pharmaceutical company Roche that it would increase production to about 250,000 doses a month next year.
Mr. Trump received an antibody cocktail on Friday, but it is not the only drug he was prescribed. He has been taking the antiviral drug rimadesivir, 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 severe cases of Covid-19.
In an interview Wednesday before the company’s announcement, Dr. George Yankopoulos, president and chief scientific officer of Regeneron, said Mr. Trump reacted to the treatment and the virus level dropped. “That’s a logical conclusion,” Dr. Yankopoulos said. “Based on its symptomatology, it has happened.”
But neither Dr. Neither Yankopolos nor Mr. Trump can say for sure whether the treatment works. Any number of factors can complicate the picture, including the fact that most people who are infected with the virus recover. That is why drugs are usually tested in large clinical trials with hundreds and sometimes thousands of people.
UCSF Health’s infectious disease specialist in San Francisco, Dr. Peter Chin-hong, in his opinion, said there was a “not ten million percent” chance that Regiron’s treatment could cure Mr. Trump in 24 hours, as the president claimed.
The second 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 a feeling of well-being and happiness in patients. “All of this is done with dexamethasone in mind,” said Chin Chin-hong.
Gina Kolata contributed to the reporting.
