Remdesivir, the antiviral drug developed by American firm Gilead Sciences, has become the first in the United States to be approved for use in the treatment of Covid-19 patients, days after the World Health Organization (WHO) said it offered limited benefits.
Following an emergency use authorisation (EUA) issued on May 1, the drug, sold under the brand name Veklury, was approved for hospital use in adults and children aged 12 and above, the US Food and Drug Administration (FDA) said on Thursday.
The EUA was altered to allow for continued access for children weighing at least 3.5kg (7.7 pounds) but not more than 40kg, or hospitalised paediatric patients under 12 and weighing at least 3.5kg. Clinical trials assessing the safety and efficacy of Veklury in the paediatric patient population were ongoing, the statement said.
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An EUA refers to the practice by which unapproved medical products or unapproved uses of approved medical products are permitted in emergency situations.
Veklury was granted conditional approval by the European Union and Australia in July for treating adult and adolescent Covid-19 patients with severe symptoms in hospital. US President Donald Trump was given the drug earlier this month.
The FDA said the approval was based on analysis of data from three clinical trials using people with mild to severe symptoms.
One of the trials, conducted by the National Institute of Allergy and Infectious Diseases, showed recovery from Covid-19 was 10 days for the Veklury group compared to 15 days for a placebo group.
The results were published in T he New England Journal of Medicine this month.
The approval came just days after the WHO’s Solidarity trial, involving more than 11,000 people in 405 hospitals in 30 countries, found the drug had little effect on mortality, reducing the length of hospital stays or whether patients needed a ventilator.
The results of the study were made public before being peer-reviewed.
David Hui, an expert in respiratory medicine at Chinese University of Hong Kong, questioned the results of the WHO trial.
“The Solidarity trial was limited by several major factors: no data monitoring, no placebo control, no double-blinding, no diagnostic confirmation of infection. It has very poor study design,” he said.
“The trial with placebo control published in New England Journal of Medicine showed that remdesivir can shorten the duration of illness by five days and this is an important endpoint.”
Gilead Sciences said last week that the Solidarity trial was a “multi-centre, open-label global trial designed to provide early access to remdesivir to patients around the world and the trial design prioritised broad access, resulting in significant heterogeneity in trial adoption, implementation, controls and patient populations”.
Stuart Ralph, an associate professor at the University of Melbourne, said the shorter recovery times suggested by the clinical trial were a clinical benefit for patients but the drug appeared not to have had a significant on death rates.
“That’s not to say that it won’t have any beneficial role as a part of our toolkit against Covid-19, but it doesn’t seem that Remdesivir by itself will be the answer to the hundreds of thousands of people dying from Covid-19,” he said.
“Physicians will be aware that many of those seriously ill patients who need hospitalisation will still die from Covid-19 even after treatment with Remdesivir.”
Paul Sax, a professor of medicine at Harvard Medical School wrote in Journal Watch that the greatest benefit of remdesivir would be in patients with shorter duration of symptoms, whereas the Solidary trial began enrolment in March and for much of the enrolment period, patients with Covid-19 did everything they could to avoid going to hospital.
“For many, I suspect the short window of time for this antiviral to benefit had closed by the time they were admitted,” he said.
Whether remdesivir actually worked was “a cautious maybe”, Sax said, adding he would still recommend it for most people being treated in hospital.
“But if we can learn anything from the mental gyrations required to square these conflicting study results, it’s that we definitely need more effective options.”
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