The drug President Donald Trump believes “cured” his COVID-19 isn’t approved for use for ordinary Americans and still must clear many regulatory hurdles before it is.
For the experimental monoclonal antibodies from Regeneron to be available as an approved treatment for the disease, it must go through a truncated approval process called an Emergency Use Authorization, which is only allowed in the case of national health emergencies.
Such an emergency was declared Jan. 31, by U.S. Health and Human Services Secretary Alex Azar for the COVID-19 pandemic.
Regeneron applied for an EUA on Wednesday as did Eli Lilly and Co., which is making a similar product.
This fast-tracked EUA application differs from a regular drug license application in several ways but the company still has to prove to the Food and Drug Administration the drug is safe and effective.
Despite the president’s remarks, that’s not yet known.
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An EUA can be issued based on early data, at the discretion of FDA scientists. It still has to go through testing but the application can be expedited because “there are no adequate, approved and available alternatives,” according to FDA regulations.
The agency can then issue an authorization for release if it finds it is “reasonable to believe” the drug may be effective.
That’s different from the regular approval process, which requires that “the drug is determined to provide benefits that outweigh its known and potential risks,” according to FDA.
EUA approvals can occur quickly because the bar is so low – simply that the approved treatment may do more good than harm, said Dr. Tom Frieden, former director of the Centers for Disease Control and Prevention.
“It will be important, regardless of EUA status, that rigorous studies are done so that we can learn the optimal timing, dosage, and patients who 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 initiative designed to prevent epidemics and cardiovascular disease.
Regular drug approval requires FDA to review applications within 10 months. A priority review designation for drugs that offer “major advances in treatment or provide treatment where none existed” takes six months, according to the agency.
An EUA is even faster than a priority review but has no set timetable, said FDA spokesperson Chanapa Tantibanchachai.
“Submissions are reviewed on a case-by-case basis,” she said. “How long it takes for them to be approved or denied depends on the nature of the submission, the circumstances of the emergency, and the workload of the review staff.”
FDA is working overtime to get drugs and treatments out.
In a presentation Wednesday to the American Medical Association, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, said the agency is working full-out to review COVID-19 vaccines and treatments.
“We’re about a 20-hour-a-day shop now, 22-hours-a-day in terms of the various shifts that are working,” he said.
An EUA could come very quickly if the FDA feels Regeneron’s data is solid or, some fear, due to influence from the White House.
There has been concern in the past few months about political pressure being brought to bear on FDA to approve other drugs the president has touted, such as hydroxychloroquine. That drug was pushed strongly by Trump and was initially approved for emergency use, which was later revoked.
On Thursday, the heads of five infectious disease medical societies called upon FDA to base any approvals on established scientific standards.
“Promising results among small numbers of patients” taking antibody therapies are not a substitute for the rigorous scientific review, their letter said.
“We urge FDA to apply its highest standards and act with appropriate deliberation on the EUA application,” the association heads wrote in a rare joint letter. “As we face the work ahead, the tragic toll of this pandemic demands a response guided by science and solidarity.”
If Regeneron were to receive an EUA for its monoclonal antibody treatment, it would not mean the company could market it long term.
An EUA does not entitle a company to skip the full drug application process. EUAs issued for a given drug expire when the emergency declaration expires. A company must continue through the normal licensing sequence for its product to be approved when an emergency ends.
The Regeneron drug, REGN-COV2, is composed of a pair of monoclonal antibodies that mimic the natural process of the immune system, providing it with molecules the body normally manufactures to fight off specific diseases.
It is currently being tested in people at various stages of COVID-19, including patients who have been diagnosed and are symptomatic but not hospitalized, as was Trump.
It also is being considered as a prophylactic treatment to prevent infection in people who have been exposed to SARS-CoV-2, the virus that causes COVID-19.
This article originally appeared on USA TODAY: Trump’s COVID antibody treatment needs FDA emergency use authorization