World Health Organisation (WHO) on Friday, 20 November, suspended Gilead’s drug Remdesivir from its ‘prequalification list’, which is an official list of medicines used as a benchmark for procurement by developing countries, Reuters reported.
“The suspension is a signal to countries that WHO, in compliance with the treatment guidelines, does not recommend countries procure the drug for COVID,” a communications officer at WHO told Reuters in an email response.
WHO Advises Against Use of Remdesivir
Earlier in the day, WHO had advised against the use of Gilead’s drug Remdesivir for patients hospitalised with COVID-19 irrespective of how ill they were because of inadequate evidence that the drug improves survival or the need for ventilation.
The WHO Guideline Development Group (GDG) reviewed new evidence comparing several drug treatments on over 7,000 patients in four international randomised trials.
“The panel found a lack of evidence that Remdesivir improved outcomes that matter to patients such as reduced mortality, need for mechanical ventilation, time to clinical improvement, and others,” said the expert panel, which included four patients who had COVID-19, reported Al Jazeera.
Remdesivir, developed by US pharmaceutical company Gilead Sciences, is one of the only two medicines currently authorised to treat COVID-19 patients, after early trials of the drug showed promise in curing the pandemic that first emerged in China late last year, reported Reuters.
However, the Solidarity Trial, a WHO-led initiative in October, projected that the antiviral drug had little or no effect on the survival of patients or the length of their hospital stay. Gilead has questioned the Solidarity Trial’s results, reported Al Jazeera.
WHO noted after reviewing the evidence that given the remaining possibility of important harm, as well as the relatively high cost associated with Remdesivir, which needs to be administered intravenously, the recommendation was “appropriate”, reported Al Jazeera.
“Especially given the costs and resource implications associated with Remdesivir the panel felt the responsibility should be on demonstrating evidence of efficacy, which is not established by the currently available data,” it added.
Early Trial Evidence Of Remdesivir Was Promising
In July, Gilead priced Remdesivir at $2,340 for a five-day treatment in the US and some other developed countries, reported Al Jazeera.
The WHO panel said, however, that it supported continued enrolment into clinical trials evaluating Remdesivir in patients with COVID-19, which it said should “provide higher certainty of evidence for specific groups of patients”.
The medication was given emergency-use authorisation from the Food and Drug Administration in the US on 1 May and had secured regulatory approval in over 50 countries. The drug was used to treat US President Donald Trump’s COVID-19 infection in early October.
The WHO’s recommendation is not binding and is part of the “living guidelines” project that offers guidance to doctors in fast-moving medical situations such as the covid-19 which has been a global health crisis. The guidelines are updated from time to time based on new evidence from medical trials. Gilead has yet to release full clinical study reports on Remdesivir, reported Al Jazeera.
(With inputs from Al Jazeera and Reuters)
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