The FDA gives Trump an emergency permit for antibody treatment

The Food and Drug Administration has given urgent permission for experimental antibody treatment given shortly after President Trump was diagnosed with Covid-19, and as cases continue to grow nationwide, doctors are treated separately for Covid-19 patients. Gave you the choice.

This treatment, performed by biotechnology company Regeneron, has been shown to be promising in early studies to control infections and reduce the number of patients taking medication in the early stages of the disease. It is an antibody cocktail. A similar treatment given by Eli Lilly was given urgent approval earlier this month.

Emergency licenses for Regeneron drugs are limited in scope. It is intended for people over the age of 12 who test positive for coronavirus and are at high risk of developing severe Covid-19. Evidence to date suggests that antibody treatment is most effective in the early stages of the disease, before the virus builds a foothold in the body. As with Eli Lilly’s treatment, Regeneron is not approved for use in hospitalized or in need of oxygen.

With an average of more than 168,000 people diagnosed with Covid-19 daily in the United States and lack of hospital beds in some parts of the country, emergency permits immediately raise questions about who will be treated. .. Regeneron says it will provide enough medication to about 80,000 patients by the end of November, 200,000 by the first week of January, and 300,000 by the end of January. Later, the company said it could expand production through a partnership with Swiss manufacturer Roche.

Regeneron has received over $ 500 million from the federal government for the development and manufacture of treatments, a complex and time-consuming process. The first 300,000 doses will be provided free of charge, but patients may be billed for treatment. Must be injected at a clinic or hospital.

Although antibody therapy has received less attention than vaccines, health officials have long hoped that it could serve as a possible bridge for antibody therapy until the coronavirus vaccine became more widely available. Recently, two vaccines, Pfizer and Moderna, have been shown to be more than 90% effective in early analysis. Pfizer, who completed the trial, filed an application for an emergency vaccine permit on Friday, saying Moderna will soon apply. Still, it takes weeks for the vaccine to become available, yet access is restricted to people in high-risk groups.

George D, President and Chief Scientific Officer of Regeneron. Dr. Yancopoulos said in a statement that he was encouraged by the results of recent vaccines, but said, “Patients with Covid-19 need to be treated. They are not protected by access to vaccination or vaccination. It was. “

Regeneron was touted in October after Mr. Trump was enthusiastically promoting the drug to give him a superpower feel after receiving a cocktail Video released On October 7, the president claimed that he had approved it, without evidence that it had cured him — he has no power to do it.

It remains impossible to know if regeneron treatment helped Mr. Trump. He was given multiple medications while at the Walter Reed National Military Medical Center, and many people recovered from the virus themselves.

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

A similar antibody therapy developed by Regeneron to fight Ebola was approved by the FDA in October, strengthening confidence that its Covid-19 version will become widespread in ongoing trials in outpatients.

The president and two of his chief advisers, Mark Meadows, White House Chief of Staff, and Jared Kushner, Trump’s son-in-law, have called on FDA Commissioner Dr. Stephen M. Hahn for speed. It was. Agency reviews. And Dr. Leonard S. Schleifer, co-founder of the billionaire and CEO of Regeneron, who has known Mr. Trump casually for years, asks Mr. Trump about the status of his treatment. I told my friends that I called.

According to early data released by Regeneron, this cocktail is ideal for people who do not appear to have initiated an initial immune response to the virus, or who are at high risk of being unlucky due to high levels of the virus.

However, early evidence also shows that antibody treatment does not work well when people are ill enough to be hospitalized. Eli Lilly has discontinued treatment of inpatients in a government-run trial. This is because he said he didn’t seem to help the inpatients. And Regeneron has suspended enrolling the most ill inpatients in one of its trials.

This poses a challenge in drug distribution, as it is only allowed for non-hospitalized people, but needs to be injected intravenously in clinics and hospitals.

Regeneron suggests that the greatest beneficiaries of treatment are those who have not yet initiated an antibody response and are high in viral load. However, knowing who they are requires individual tests that are not performed on a regular basis for the patients being tested. Virus positive. Company executives initially acknowledge that such tests may not be available, and emergency permits are for those over 65 years of age or for underlying illnesses such as obesity and diabetes. It states that some people are included.

Treating the right people requires rapid turnaround of testing and coordination between federal, state, and hospital staff. This is many of the same challenges that complicate the US response to a pandemic.

Distributor AmerisourceBergen offers treatment for Regeneron on a weekly schedule based on the number of Covid-19 cases in each state. The federal government plans to work with state health authorities to determine which hospitals and clinics should receive it.

In a call with a reporter this month to outline how Eli Lilly treatment will be distributed, Federal Drug Chief Executive Janet Woodcock said the government is working with hospitals and infusion companies. The administration stated that the logistic complexity of the drug, which took 1 hour, was observed, followed by 1 hour of observation. Hospitals and clinics also need to understand how to safely treat infected patients without exposing others to the virus.

“Up to this point, people are told to stay home unless they get very ill, so high-risk people need to let us all know that they now have treatment options as outpatients.” She said.

The Emergency License (EUA) was previously an ambiguous part of regulatory law and was widely distracted by the general public. But during the pandemic, it became the center of government health policy: since February, the agency has granted hundreds of emergency approvals related to Covid-19, many for diagnostic tests and others. For personal protective equipment, blood purifiers, ventilators and treatments.

In approving the urgent approval, FDA infectious disease department scientists need to consider the need for clear evidence that treatment worked with growing despair for useful drugs as the pandemic accelerated again in the United States. had. Unlike full FDA approval, which requires rigorous review of clinical trial data showing that a drug is safe and effective, emergency permits simply require that the potential benefits of the drug outweigh its risks. I will.

Regeneron’s urgent permission can have the unintended effect of complicating the role of clinical trials in demonstrating the effectiveness of treatment for different age groups. As the drug becomes more widely available, fewer people will want to enroll in clinical trials and there is a risk of receiving a placebo.

Regeneron’s clinical trials are continuing in studies investigating whether treatment can prevent infections in people infected with Covid-19, as well as inpatients.

The FDA gives Trump an emergency permit for antibody treatment

Source link The FDA gives Trump an emergency permit for antibody treatment

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