FDA grants emergency clearance for Trump antibody treatment

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The Food and Drug Administration granted emergency clearance for the experimental antibody treatment given to President Trump shortly after he was diagnosed with Covid-19, giving doctors another option to treat Covid-19 patients as cases across the country continue to rise.

The treatment, made by biotech company Regeneron, is a cocktail of two potent antibodies that have shown promise in early studies to control infection, thereby reducing doctor visits in patients who receive the drug early in their illness. . A similar treatment, performed by Eli Lilly, received emergency approval earlier this month.

The emergency authorization for the drug Regeneron has a limited scope: it is aimed at people 12 years of age and over who have tested positive for the coronavirus and who are at high risk of developing severe Covid-19. So far, the evidence suggests that antibody treatments work best early in the course of the disease, before the virus takes hold in the body. Like Eli Lilly’s treatment, Regeneron’s is not allowed in people who are hospitalized or in need of oxygen.

Emergency clearance raises immediate questions about who will have access to treatment, as on average more than 168,000 people are diagnosed with Covid-19 every day in the United States and hospitals are running out of beds in some areas from the country. Regeneron said it would have enough for only 80,000 people by the end of November, enough for 200,000 patients in the first week of January and 300,000 by the end of January. After that, the company said it would be able to increase production through a partnership with Swiss manufacturer Roche.

Regeneron has received more than $ 500 million from the federal government to develop and manufacture the treatments, a complex and time-consuming process. Although the first 300,000 doses are provided free of charge, patients may be billed for the treatment given; it must be infused in a clinic or hospital.

Antibody treatments have drawn less attention than vaccines, but health officials have long hoped they could serve as a bridge until a vaccine for the coronavirus became more widely available. Two vaccines, one made by Pfizer and the other by Moderna, have recently been shown to be over 90% effective in early analyzes. Pfizer, which has completed its trial, submitted an emergency vaccine clearance request on Friday, and Moderna said it also plans to apply soon. Still, it will be weeks before a vaccine is available, and even then, access will be limited to people in high-risk groups.

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Dr George D. Yancopoulos, President and Scientific Director of Regeneron, said in a statement he was encouraged by recent vaccine results, but “there remains a need to treat patients who develop Covid-19, especially more than some may not have had access to vaccination or were not protected by vaccination. “

Regeneron saw an explosion of publicity in October, when Mr. Trump was infused with his cocktail and then enthusiastically promoted the drug as giving him a sense of superpower. In one published video on October 7, the president claimed without evidence that it had cured him and that he had authorized it – which he had no authority to do.

Whether the Regeneron treatment helped Mr. Trump remains unclear. He received several medications at Walter Reed National Military Medical Center, and many people are recovering from the virus on their own.

Since the spring, the White House and health officials have been closely monitoring the development of antibody treatments. In addition to Regeneron’s deal with the federal government, Eli Lilly announced a $ 375,000 deal in October to provide the government with 300,000 doses.

A similar antibody treatment Regeneron developed to fight Ebola was approved by the FDA in October, boosting confidence that its Covid-19 version would prevail in ongoing outpatient trials.

The president and two of his top advisers – Mark Meadows, the White House chief of staff, and Jared Kushner, Mr Trump’s son-in-law – called on Dr Stephen M. Hahn, the FDA commissioner, to lobby to speed up agency notice. And Dr. Leonard S. Schleifer, the billionaire co-founder and chief executive of Regeneron, who has known Mr. Trump casually for years, told his associates that Mr. Trump was calling him to ask about the status of the treatment.

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The first data published by Regeneron suggests that its cocktail works best in people who do not appear to develop an early immune response to the virus, or who have high levels of the virus, and are therefore more at risk of doing badly.

But early evidence also shows that antibody treatments don’t work well once people are sick enough to be hospitalized. Eli Lilly has stopped giving his treatment to hospital patients in a government-led trial because he said he did not appear to be helping those patients. And Regeneron has suspended the recruitment of the sickest hospital patients in one of its trials.

This poses a challenge for the distribution of drugs, as they are only allowed for people who are not hospitalized, but need to be infused intravenously in a clinic or hospital.

Regeneron suggested that the people who benefit the most from treatment are those who have not yet developed an antibody response and also have a high viral load – but learning who these people are would require separate tests that are not routinely given to patients. patients who test. positive for the virus. Company executives have acknowledged that at first such tests may not be available, and the emergency clearance says people at high risk include those over 65 or with conditions under. – related such as obesity or diabetes.

Getting treatment to the right people will require quick turnaround times in testing, as well as coordination between federal, state and hospital authorities – many of the same challenges that have complicated the US response to the pandemic.

Distributor AmerisourceBergen will deliver Regeneron treatment on a weekly schedule based on the number of Covid-19 cases in each state. The federal government plans to work with state health officials to determine which hospitals and clinics should benefit.

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In a call with reporters this month to explain how the Eli Lilly treatment would be distributed, Janet Woodcock, a senior federal drug official, said the administration was working with hospitals and infusion companies and acknowledged the complexity logistics of a drug that takes an hour. to administer, followed by an hour of observation. Hospitals and clinics will also need to figure out how to safely treat infectious patients without exposing others to the virus.

“We’re all going to need to make it known that people at high risk now have an outpatient treatment option, because until now people have been told to stay home unless they get very sick,” she declared.

Emergency Use Authorization, or EUA, was previously an obscure piece of regulatory law that largely escaped the attention of the general public. But during the pandemic, it became a centerpiece of the administration’s health policy: since February, the agency has granted hundreds of emergency clearances related to Covid-19, many for diagnostic tests and others for personal protective equipment, blood purification devices, ventilators. and therapies.

In approving emergency clearances, FDA scientists at the agency’s Office of Infectious Diseases had to weigh the need for clear evidence that treatments were working with the growing desperation for helpful drugs as the pandemic accelerated to new to the United States. Unlike full FDA approval, which requires rigorous verification of clinical trial data showing that a drug is safe and effective, emergency clearance simply requires that a drug’s potential benefits outweigh its potential benefits. risks.

The emergency authorization of Regeneron may still have the unintended effect of complicating the role of clinical trials in demonstrating the efficacy of treatment for different age groups. If the drug becomes more widely available, fewer people may want to enroll in clinical trials and risk receiving a placebo.

Regeneron clinical trials are continuing in hospitalized patients as well as studies to determine whether treatment can prevent infections in people who have been exposed to someone with Covid-19.

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