FDA EUA Allows States to Receive Unapproved COVID-19 Treatments

Regulatory NewsRegulatory News | 30 March 2020 |  By 

Opening the door to the wider use of unapproved but potential COVID-19 treatments, the US Food and Drug Administration (FDA) late Sunday issued an emergency use authorization (EUA) to allow the US Biomedical Advanced Research and Development Authority (BARDA) to distribute donated hydroxychloroquine sulfate and chloroquine phosphate products to doctors, who can decide whether to prescribe them to hospitalized teen and adult patients with COVID-19 when a clinical trial is not available or feasible.

This is FDA’s first EUA for a therapeutic product to potentially treat COVID-19.

The donations to be distributed, the Department of Health and Human Services (HHS) said Sunday, include 30 million doses of hydroxychloroquine sulfate from Novartis' Sandoz and one million doses of chloroquine phosphate from Bayer Pharmaceuticals. Hydroxychloroquine sulfate and chloroquine phosphate were previously approved by FDA to treat other conditions, including malaria and lupus.

“The suggested dose under this EUA for hydroxychloroquine sulfate to treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 for whom a clinical trial is not available or participation is not feasible, is 800 milligrams of hydroxychloroquine sulfate on the first day of treatment and then 400 milligrams daily for four to seven days of total treatment based on clinical evaluation. The suggested dose and duration may be updated as data from clinical trials becomes available,” FDA said.

“The suggested dose under this EUA for chloroquine phosphate to treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible, is 1 gram of chloroquine phosphate on day one, followed by 500 milligrams daily for four to seven days of total treatment based on clinical evaluation,” FDA added.

But some are skeptical that these treatments will provide benefits.

Luciana Borio, VP of In-Q-Tel and former FDA chief scientist, criticized the decision on Sunday, saying the EUA was issued "despite the total lack of scientific evidence that chloroquine/hydroxychloroquine are beneficial in the treatment of COVID-19. EUA is supposed to be issued when the evidence indicates that benefits outweigh the risks."

Clifford Lane, a 40-year veteran of the US National Institute for Allergy and Infectious Diseases, also told Politico last week: “I’ve looked at the available human data, I don’t see anything in that literature that appears to show any benefit.”

A recent, non-randomized observational study that did not have a control group tested the use of hydroxychloroquine and azithromycin in 80 people in Marseille, France. The researchers noted “a clinical improvement in all but one 86 year-old patient who died, and one 74 year old patient still in intensive care unit,” but some are questioning parts of the study and wondering if more, individual patient information will be released.

And HHS even concedes that although anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients, clinical trials are still necessary to provide scientific evidence that they are effective.

President Donald Trump, who has said the use of hydroxychloroquine and azithromycin “have a real chance to be one of the biggest game changers in the history of medicine,” said Sunday that they are being administered to 1,100 patients in New York as part of trials.

Other Treatments

Meanwhile, the use of another unapproved but potential COVID-19 treatment, Gilead’s antiviral remdesivir, is expanding as hospitals or physicians can apply for emergency use of remdesivir for multiple severely ill patients at a time, Gilead CEO Daniel O’Day said in an open letter over the weekend.

“While it will take some time to build a network of active sites, this approach will ultimately accelerate emergency access for more people. Initial sites in the United States are up and running as of yesterday, and it is expected that sites in additional countries will be activated soon,” he wrote, noting remdesivir has been used in more than 1,000 patients so far.

Last week, Gilead came under scrutiny after obtaining an orphan drug designation for remdesivir but the company ultimately asked FDA to rescind the designation. O’Day also said the previous compassionate use program for remdesivir will continue for children and pregnant women.

Meanwhile, Regeneron Pharmaceuticals and Sanofi said Monday that the first patient outside of the US has been treated as part of a Phase 2/3 trial evaluating Kevzara (sarilumab) in patients hospitalized with severe COVID-19. The trial has been initiated in Italy, Spain, Germany, France, Canada, Russia and the US.

"Data from a single-arm study in China suggest that the interleukin-6 pathway may play an important role in the overactive inflammatory response in the lungs of patients with COVID-19," said George Yancopoulos, chief scientific officer of Regeneron.

Letter of Authorization to BARDA



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