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

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

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

The drug maker Regeneron stated on Wednesday night that it had submitted an utility 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 “remedy” for the coronavirus.

The corporate stated that at the beginning, entry to the therapy can 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 accessible to People 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 instantly made him really feel higher. “I felt unbelievable,” he stated. “I felt good instantly.”

There isn’t a proof that the therapy is the explanation he was feeling higher, and his docs have stated he has taken different medicine as nicely.

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

Mr. Trump seemed that he would push the F.D.A. to approve Regeneron’s therapy, although the company’s scientists are presupposed to make unbiased selections about approvals.

“I’ve emergency use authorization all set, and we’ve bought 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 verify or deny product functions.

The information of Regeneron’s utility 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 businesses to make selections geared toward benefiting him politically. Within the video, Mr. Trump repeated his want to get a vaccine accepted earlier than the election, although the vaccine makers themselves have stated that’s extremely unlikely.

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

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

The corporate has acquired greater than $500 million from the federal authorities to develop and manufacture its experimental therapy 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 accessible.

The corporate stated that it expects to have doses accessible for 300,000 sufferers within the subsequent few months. Beneath the settlement with the federal authorities, it stated these doses can be made accessible 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 isn’t 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 suggest just for individuals who have extreme or crucial instances 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 therapy 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 therapy 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 sometimes examined in massive medical trials with tons of and generally 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 % no” probability that the Regeneron therapy might have cured Mr. Trump in 24 hours, because the president claimed.

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

Gina Kolata contributed reporting.

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