FDA gives emergency authorization of anti-treatment treatment given to Trump

Food and Drug Administration is Emergency authorization granted President Trump was soon diagnosed with Kovid-19 for experimental antibody treatment, giving doctors another option to treat Kovid-19 patients as cases are increasing across the country.

Treatment done by Biotech Company Regeneron, Is a cocktail of two potent antibodies that have shown promise in early studies taking into account infection, reducing medical visits in patients who receive the drug early during their illness. A similar treatment by Eli Lilly was granted emergency approval. Earlier this month.

The emergency authorization for Regeneron’s drug is limited in scope: it is for 12 people and those who have tested positive for coronovirus and who are at high risk for developing severe Kovid-19. Evidence so far suggests that antibody treatments work best in the treatment of the disease before the virus has accumulated in the body. Like Eli Lilly’s treatment, Regeneron is not authorized for use in people who are hospitalized or who need oxygen.

The Emergency Authority immediately raises questions about who will get access to treatment Average of over 168,000 people In the United States, Kovid-19 is diagnosed each day and hospitals in some areas of the country are running out of beds. Regeneron has said it will have enough medicine for only 80,000 people by the end of November, enough for 200,000 patients by the first week of January, and 300,000 by the end of January. After that, the company said that it would be able to ramp up production due to a partnership with Swiss manufacturer Roshe.

Regineron has received more than $ 500 million from the federal government to develop and build remediation, a complex and time-consuming process. Although the first 300,000 doses will be provided free of charge, patients can be administered for treatment; It should be violated in a clinic or hospital.

Antibody treatment has received less attention than vaccines, but health officials have long hoped that they could serve as a potential bridge until a coronovirus vaccine is more widely available. Two vaccines, one made by Pfizer and Second by modern, Were recently shown to be more than 90 percent effective in preliminary analyzes. Pfizer, which has completed its test, Submitted an application on friday To the Emergency Authority of the Vaccine, and Modern said there are plans to implement it soon. Nevertheless, it would be weeks before the vaccine became available, and even then, access to people in high-risk groups would be limited.

The Chairman and Chief Scientific Officer of Regeneron, Dr. George D. Yancopoulus said in a statement that he was encouraged by the recent vaccine results, but “needs treatment for patients who develop Kovid-19, especially as some may not.” Not reached or protected by vaccination. “

Regeron enjoyed Bursts of publicity In October, when Mr. Trump received his cocktail infusion and then enthusiastically promoted the drug to give him a superpower-like spirit. In Video release On October 7, the president claimed without evidence that it had cured him, and that he had authorized it – something he does not have the power to do.

It is impossible to know whether the Regeneron treatment helped Mr. Trump. He was given several medications at Walter Reed National Military Medical Center, and many recovered from the virus on their own.

Since spring, White House and health officials are closely watching the development of antibody treatments. In addition to Regeneron’s deal with the federal government, Eli Lilly Announced $ 375 million deal In October to supply the government with 300,000 doses.

A similar antibody treatment that Rebner developed to fight Ebola FDA approved In October, raising confidence that its Kovid-19 version will prevail in ongoing trials of outpatients.

The President and his two top advisors – Mark Meadows, White House Chief of Staff, and Jared Kushner, Mr. Trump’s son-in-law – FDA Commissioner Dr. Stephen M. Pressed Hahn for speed. Agency Review and Drs. Leonard S. Sleifer, the billionaire co-founder and chief executive of Regeneron, who has known Mr. Trump carelessly for years, has told aides that Mr. Trump asks him about the treatment situation.

Initial data released by Regeneron suggests that its cocktail works best in people who do not increase their initial immune response to the virus, or who have high levels of the virus, and who are therefore more prone to malfunction. Risk

But early evidence also shows that antibody treatments do not work well because people are ill enough to be hospitalized. Eli Lilly Stopped giving my treatment In a government-run trial of hospitalized patients, it was stated that it did not help those patients. And Reason Hospitalization of sick hospitalized patients In one of its tests.

It is a challenge to deliver the drugs, as they are only authorized for those who are not hospitalized, yet they must be kept intravenously in a clinic or hospital.

Resenarone suggests that the people who benefit the most from treatment are those who have not yet given an antibody response and who also have high viral loads – but those needing different tests to learn Will be given regularly to patients who test positive for the virus. Company officials acknowledge that such tests may not be available at first, and the Emergency Authority notes that high-risk people include people over the age of 65, or have underlying underlying obesity or diabetes. Conditions are.

A rapid change in testing will be required to get treatment to the right people, as well as coordination between federal, state and hospital officials – Many of the same challenges Has complicated America’s response to the epidemic.

Distributor AmerisourceBergen will distribute the treatment of Regeron in a weekly schedule based on the number of Kovid-19 cases in each state. The federal government plans to meet with state health officials to determine which hospitals and clinics should receive it.

Janet Woodcock, a top federal drug official, said that in a call with reporters earlier this month, Janet Woodcock said the administration was working with hospitals and infusion companies, and acknowledged that the logical complexity of a drug Takes one hour. Administration after one hour of observation. Hospitals and clinics also have to figure out how to safely treat infectious patients without exposing the virus to others.

“We all need to get the word out that high-risk people now have a therapeutic option as an outpatient, as long as people have been told to stay home until this point they are very ill. Don’t be, “she said.

The Emergency Use Authority, or EUA, was formerly An ambiguous corner of regulatory law He mostly survived widespread public attention. But during the pandemic, it has become a focal point of the administration’s health policy: Since February, the agency has released hundreds of emergency authorities related to Kovid-19, many more personal protective equipment, blood purification equipment for clinical trials, Others are allowed for ventilators. And treatment.

In signing emergency authorities, FDA scientists at the agency’s Office of Infectious Diseases had to weigh the need for clear evidence that the treatment worked with increasing frustration for useful drugs as the epidemic intensified again in the United States . Unlike a full FDA approval, which requires a rigorous vetting of clinical trial data to show a drug that is safe and effective, an emergency authority simply needs the potential benefits of a drug in order to avoid its risks. Can be reduced.

Emergency authorization for Regeneron may still have the unintended effect of complicating the role of clinical trials in proving the effectiveness of treatment for different age groups. If the drug becomes more widely available, fewer people want to sign up for clinical trials and risk the possibility that they may receive a placebo.

Regenon’s clinical trials continue in studies on hospitalized patients as well as whether treatment can prevent infection in those who have come in contact with someone with Kovid-19.

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