The Food and Drug Administration did issued emergency permit for the experimental antibody treatment given to President Trump shortly after he was diagnosed with Covid-19, offering doctors another option to treat Covid-19 patients as cases continue to rise across the country.
Treatment by the Biotech company Regeneronis a cocktail of two strong antibodies that showed promise in early studies for keeping the infection in check and reducing the number of doctor visits for patients who receive the drug early in the course of their illness. Similar treatment for Eli Lilly was approved in an emergency earlier this month.
The emergency approval for Regeneron’s drug is limited in scope: It applies to people who have tested positive for the coronavirus and are at high risk of developing severe Covid-19. Findings to date suggest that antibody treatments are best effective early in the course of the disease, before the virus has taken hold in the body. Like Eli Lilly’s treatment, Regeneron is not approved for use in people who are hospitalized or need oxygen.
The emergency permit immediately raises questions about who, as a patient, will have access to treatments Average of more than 168,000 people In the United States, Covid-19 is diagnosed every day, and hospitals are running out of beds in some regions of the country. Regeneron has announced that it will have enough of the drug for only about 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 it can ramp up production thanks to a partnership with Swiss manufacturer Roche.
Regeneron has received more than $ 500 million from the federal government to develop and manufacture the treatments. Although the first 300,000 doses are provided free of charge, patients may be billed for the administration of the treatment. It must be infused in a clinic or hospital. For some Medicare beneficiariesThis cost would be $ 60 depending on the patient’s coverage plan.
Antibody treatments have received less attention than vaccines, but health officials have long hoped they can serve as a possible bridge until a coronavirus vaccine becomes more widely available. Two vaccines, one from Pfizer and one another from Modernawere recently shown to be more than 90 percent effective in early analysis. Pfizer, who completed its process, filed an application on Friday for emergency approval of the vaccine, and Moderna said it was also planning to apply soon. Still, it will be weeks before a vaccine becomes available, and even then, access will be restricted to people in risk groups.
Dr. George D. Yancopoulos, President and Chief Scientific Officer of Regeneron, said in a statement that he was encouraged by the latest vaccine results, but “the need to treat patients who develop Covid-19 remains, especially as some may did not have access to or not protected by vaccination. “
Regeneron enjoyed one Outbreak of advertising in October when Mr Trump was given an infusion of his cocktail and then enthusiastically promoted the drug to make him feel superpowered. In one Video released On October 7th, the president claimed without evidence that it cured and authorized him – something he is not empowered to do.
It remains impossible to know if the Regeneron treatment helped Mr Trump. He was given several drugs while 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 developments in antibody treatments. In addition to Regeneron’s contract with the federal government, Eli Lilly announced a deal for $ 375,000 in October to provide 300,000 cans to the government.
A similar antibody treatment that Regeneron developed to fight Ebola was approved by the F.D.A. in October to build confidence that the Covid-19 version will prevail in ongoing outpatient studies.
The President and two of his top advisors – Mark Meadows, White House Chief of Staff, and Jared Kushner, Mr. Trump’s son-in-law – have appointed Dr. Stephen M. Hahn, the F.D.A. Commissioner to push for speed in the agency’s ratings. And Dr. Leonard S. Schleifer, co-founder and executive director of the billionaire at Regeneron, who has known Mr. Trump casually for years, has told his staff that Mr. Trump is calling him to inquire about the status of the treatment.
Early data released 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 at greater risk of doing poorly.
This poses a challenge to the distribution of the drugs as they are only approved for use by people who are not in the hospital but require intravenous infusion in a clinic or hospital.
Regeneron has suggested that the people who will benefit most from treatment are those who have not yet developed an antibody response and who also have high viral loads. However, to learn who these people are would require separate tests, which are not routinely done on patients who test positive for the virus. Company executives have acknowledged that such tests may not be available initially, and the emergency clearance states that high-risk individuals are those over 65 years of age or have underlying conditions such as obesity or diabetes.
Getting treatment to the right people requires rapid testing, as well as coordination between federal, state, and hospital officials. many of the same challenges that has complicated the US response to the pandemic.
Distributor AmerisourceBergen will conduct Regeneron treatment weekly 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 receive these.
Speaking to reporters earlier this month outlining how to distribute treatment with Eli Lilly, Janet Woodcock, a leading federal drug commissioner, said the administration worked with hospitals and IV companies and recognized the logistical complexities of a drug which takes an hour to administer, followed by an hour of observation. Hospitals and clinics also need to figure out how to safely treat infectious patients without exposing other people to the virus.
“We all need to make it known that people at high risk now have an outpatient therapeutic option because up until that point people have been told to stay home unless they become very sick,” she said.
The emergency permit or E.U.A. was before a dark corner of regulatory law this largely escaped widespread public attention. However, during the pandemic, it has become a core part of government health policy: since February, the agency has issued hundreds of emergency clearances related to Covid-19, many for diagnostic tests and others for personal protective equipment, blood purification devices and ventilators and therapies.
When signing the emergency permits, F.D.A. Scientists at the agency’s infectious diseases bureau had to weigh the need for clear evidence that the treatments worked with the growing desperation for beneficial drugs as the U.S. pandemic accelerated again. In contrast to a full F.D.A. An approval that requires rigorous review of clinical trial data that show a medicine is safe and effective. Emergency approval only requires a drug’s potential benefits to outweigh its risks.
Emergency clearance for Regeneron may still 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 may want to sign up for clinical trials and risk the possibility of receiving a placebo.