The drug maker Regeneron stated on Wednesday night that it had submitted an software to the Meals and Drug Administration for emergency approval of the experimental antibody cocktail that President Trump had praised simply hours earlier with out proof as a “treatment” for the coronavirus.

The corporate stated that at the beginning, entry to the remedy could be extraordinarily restricted, with solely sufficient doses for 50,000 sufferers, a far cry from the “tons of of 1000’s” of doses that Mr. Trump stated in a video launched Wednesday he would quickly be making out there to Individuals freed from cost.

Within the five-minute video, Mr. Trump stated that it was a “blessing from God” that he had been contaminated with the coronavirus and that the Regeneron cocktail had abruptly made him really feel higher. “I felt unbelievable,” he stated. “I felt good instantly.”

There isn’t any proof that the remedy is the rationale he was feeling higher, and his medical doctors have stated he has taken different medicine as properly.

“I name {that a} treatment,” Mr. Trump stated within the video, including that he would be sure it was in each hospital as quickly as attainable.

Mr. Trump appeared that he would push the F.D.A. to approve Regeneron’s remedy, though the company’s scientists are imagined to make impartial selections about approvals.

“I’ve emergency use authorization all set, and we’ve obtained to get it signed now,” Mr. Trump stated.

A spokeswoman for the F.D.A. declined to touch upon Wednesday, saying the company doesn’t affirm or deny product purposes.

The information of Regeneron’s software on the identical day that Mr. Trump effusively praised the unproven drug is prone to intensify fears that the president is pressuring federal well being companies to make selections aimed toward benefiting him politically. Within the video, Mr. Trump repeated his need to get a vaccine accredited earlier than the election, though the vaccine makers themselves have stated that’s extremely unlikely.

Regeneron’s remedy is a cocktail of two highly effective antibodies which might be believed to spice up the immune response to the virus. Early outcomes appear promising. In a press release, the corporate has stated the cocktail lowered virus ranges notably in individuals who had not made their very own antibodies, however the firm has not but launched detailed knowledge to again up its declare. Scientific trials are usually not but full.

Medication are usually not typically thought of to be confirmed secure or efficient till they endure rigorous scientific trials that evaluate one group of people that acquired the remedy with those that obtain a placebo.

The corporate has received more than $500 million from the federal authorities to develop and manufacture its experimental remedy as a part of Operation Warp Pace, the federal effort to give you viable vaccines and coverings for the virus and to assist distribute them as soon as they’re out there.

The corporate stated that it expects to have doses out there for 300,000 sufferers within the subsequent few months. Underneath the settlement with the federal authorities, it stated these doses could be made out there freed from cost. In August, it introduced a partnership with the pharmaceutical firm Roche to ramp up manufacturing to about 250,000 doses a month by subsequent yr.

Mr. Trump acquired the antibody cocktail on Friday, however it’s not the one drug that he was prescribed. He has been taking the antiviral drug remdesivir, in addition to the steroid dexamethasone, which the World Well being Group and Nationwide Institutes of Well being advocate just for individuals who have extreme or vital circumstances of Covid-19.

In an interview on Wednesday earlier than the corporate’s announcement, Dr. George Yancopoulos, Regeneron’s president and chief scientific officer, stated it was attainable that Mr. Trump responded to the remedy and that the extent of virus had declined. “That’s a logical conclusion,” Dr. Yancopoulos stated. “Based mostly on his symptomology, that has to have occurred.”

However neither Dr. Yancopoulos nor Mr. Trump can definitively say whether or not the remedy labored. Any variety of elements might complicate the image, together with the truth that most people who find themselves contaminated with the virus recuperate. That’s the reason medicine are usually examined in giant scientific trials with tons of and typically 1000’s of individuals.

Dr. Peter Chin-Hong, an infectious illness specialist at U.C.S.F. Well being in San Francisco, stated in his opinion, there was “a million p.c no” probability that the Regeneron remedy might have cured Mr. Trump in 24 hours, because the president claimed.

One other rationalization, he stated, is that the president is experiencing the consequences of the steroid dexamethasone, which he has been receiving since Saturday, which is understood to cut back fever and might create emotions of well-being and euphoria in sufferers. “That is all in line with the dexamethasone talking,” Dr. Chin-Hong stated.

Gina Kolata contributed reporting.



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