What would be required to get Trump's new favorite COVID-19 antibody treatment on the market?
Drug President Donald Trump believes his COVID-19 is "cured" and is not approved for use by ordinary Americans. It still has many regulatory hurdles to overcome before it can.
In order for Regeneron's experimental monoclonal antibodies to be available as an approved treatment for the disease, an abbreviated approval process known as an emergency approval must be completed and is only allowed in national health emergencies.
One such emergency was declared a COVID-19 pandemic by US Secretary of Health Alex Azar on January 31.
Regeneron applied for an EUA on Wednesday, as did Eli Lilly and Co., who make a similar product.
This expedited EEA application differs in several ways from a regular drug approval application, but the company has yet to demonstrate to the Food and Drug Administration that the drug is safe and effective.
Despite what the President said, this is not yet known.
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An EUA can be issued based on early data at the discretion of FDA scientists. It has yet to be tested, but the application can be expedited as "there are no adequate, approved, and available alternatives," per FDA regulations.
The agency may then approve a release if it believes it is “reasonable to believe” that the drug may be effective.
This differs from the regular approval process, in which, according to the FDA, "the drug should provide a benefit that outweighs the known and potential risks".
EEA approvals can be done quickly because the bar is so low - simply that the approved treatment can do more good than harm, said Dr. Tom Frieden, former director of the Centers for Disease Control and Prevention.
"Regardless of EEA status, it will be important that rigorous studies are carried out so that we can determine the optimal timing, dosage and patients who will benefit from this treatment if it is found to be beneficial," said Frieden, who is now President and CEO of Resolve to Save Lives, an epidemic and cardiovascular disease prevention initiative.
For drug approval on a regular basis, the FDA must review applications within 10 months. A priority review for drugs that "offer significant advances in treatment or treatment where there has not been" takes six months, according to the agency.
An EEA is even faster than a priority review, but it doesn't have a set schedule, said FDA spokesman Chanapa Tantibanchachai.
"Submissions will be considered on a case-by-case basis," she said. "How long it takes to approve or reject them depends on the nature of the filing, the circumstances of the emergency, and the workload of the review staff."
The FDA is working overtime bringing out drugs and treatments.
In a presentation Wednesday to the American Medical Association, Dr. Peter Marks, director of the Center for Evaluation and Research of Biologics at the FDA, said the agency is working hard to review COVID-19 vaccines and treatments.
"We're now about 20 hours a day, 22 hours a day in terms of the various shifts that are working," he said.
An EEA could come very quickly if the FDA believes Regeneron's data is solid or out of fear of the White House's influence.
In recent months there have been concerns that political pressure could be put on the FDA to approve other presidential-touted drugs, such as hydroxychloroquine. This drug was strongly promoted by Trump and initially approved for the emergency, which was later revoked.
On Thursday, the heads of five infectious disease medical societies urged the FDA to base all approvals on established scientific standards.
"Promising results in a small number of patients" taking antibody therapies are no substitute for rigorous scientific scrutiny, it says in their letter.
"We urge the FDA to apply their highest standards and to examine the EUA application appropriately," wrote the association leaders in a rare joint letter. "With the work ahead, the tragic toll of this pandemic requires a response that is science and solidarity-led."
If Regeneron were to receive an EEA for its monoclonal antibody treatment, it would not mean the company could market it in the long term.
An EUA does not entitle a company to skip the complete drug application process. EUAs issued for a specific drug expire when the emergency declaration expires. A company must go through the normal licensing sequence for its product to be approved in an emergency.
The Regeneron drug REGN-COV2 is made up of a pair of monoclonal antibodies that mimick the natural process of the immune system, supplying it with molecules the body normally makes to fight off certain diseases.
It is currently being tested on people at various stages of COVID-19, including those who have been diagnosed and are symptomatic but have not been hospitalized, as has Trump.
It is also considered a prophylactic treatment to prevent infections in people who have been exposed to SARS-CoV-2, the virus that causes COVID-19.
This article originally appeared in the US TODAY: Trump's COVID Antibody Treatment Requires FDA Emergency Clearance
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