A World Health Organization panel said on Friday there is no evidence Gilead’s remdesivir improves survival or reduces the need for ventilation and did not recommend the drug for all patients hospitalized with Covid-19.
The WHO’s Guideline Development Group (GDG) issued the guideline citing “a lack of evidence that remdesivir improved outcomes that matter to patients such as reduced mortality, need for mechanical ventilation, time to clinical improvement,” among other things.
The drug, called Veklury, or remdesivir, was seen as a potentially effective treatment for the coronavirus in the summer after early trials, and was even used to treat US President Donald Trump.
The panel based its conclusion on an evidence review, including data from four international randomized trials involving more than 7,000 patients.
The recommendation is not binding, and the panel supports continued enrolment into clinical trials, which should “provide higher certainty of evidence for specific groups of patients.”
The US Food and Drug Administration approved remdesivir for treatment of Covid-19 in October, and the European Union last month ordered 500,000 courses of the antiviral worth €1 billion.
However, the WHO’s Solidarity Trial showed last month that the expensive, complex to administer intravenous drug had little or no effect on 28-day mortality or length of hospital stays for Covid-19 patients.
Gilead said on November 19 that remdesivir “is recognized as a standard of care for the treatment of hospitalized patients” in guidelines from credible national organizations.
“We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment… in approximately 50 countries,” the company stated.
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