FDA approves remdesivir as COVID-19 treatment despite negative WHO study

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The US Food and Drug Administration (FDA) has approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given through an IV for patients needing hospitalisation. The Guardian reports that the drug, which California-based Gilead Sciences Inc is calling Veklury, cut the time to recovery from 15 days to 10 on average in a large study led by the US National Institutes of Health.

It had been authorised for use on an emergency basis since spring, and now has become the first drug to win full US approval for treating COVID-19.


But, says a Fierce Pharma report, the approval closely follows a large trial that showed no benefit for the therapy, and experts quickly questioned the FDA's move.

Veklury won approval to treat COVID-19 requiring hospitalisation in adults and children 12 and older. Simultaneously, the FDA issued a new emergency use authorization for certain patients under 12. The agency approved the med based on late-stage trials showing Veklury is associated with an improved time to recovery and reduced disease progression in hospitalized patients, Gilead said.

Fierce Pharma reports that just last week, though, a large trial from the World Health Organisation (WHO) cast doubts on the med’s efficacy. WHO released preliminary results from a trial of 11,266 COVID-19 patients in 30 countries on one of four drug regimens, including Veklury. The medicine “appeared to have little or no effect on hospitalized COVID-19,” the researchers wrote.

Gilead responded that it was “concerned that the data from this open-label global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.”

Weighing in on the approval, two prominent doctors said the data don’t yet support the FDA's decision. The green light was “astonishing,” Peter Bach, director of Memorial Sloan Kettering's Centre for Health Policy and Outcomes, is quoted as saying. “Of the three included studies, one lacked control, two lacked blinding, all three lacked inclusion of current standard of care,” he wrote. The results were mixed, he pointed out, and a randomised study larger than the three touted by the FDA combined was “entirely negative."

For his part, Dr Eric Topol, director of the Scripps Research Translational Institute, wondered how the drug could get a full approval based on the “mixed data.” It’s unclear whether the med works early or late, and there’s still much “unresolved,” Topol wrote.

WHO designed its trial to rapidly evaluate treatments in large patient groups. Gilead argued the broad patient group makes it “unclear if any conclusive findings can be drawn from the study results.”

Before that, a study led by the US government showed the med, tested against placebo, improved recovery times, reduced chances of patients progressing to more severe stages of illness and significantly cut the risk of death in patients on low-flow oxygen. Patients on the drug recovered five days faster than those on placebo on average, and severe patients recovered seven days faster.

For patients on low-flow oxygen, investigators recorded 70% fewer deaths in the remdesivir group than in the placebo group.

Despite questions about the data, the drug has become a standard treatment, as evidenced by its use in President Donald Trump earlier this month. The FDA authorised it for emergency use in May, and Gilead has spent much of 2020 working to scale up capacity.


Full report in The Guardian


Full Fierce Pharma report


See also

Gilead challenges WHO’s ‘conclusive evidence’ on repurposed drugs

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