Gilead's remdesivir is not recommended for patients hospitalised with COVID-19, regardless of how ill they are, as there is no evidence the drug improves survival or reduces the need for ventilation, a World Health Organisation panel says.
"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," the guideline says.
The advice is another setback for the drug, which grabbed worldwide attention as a potentially effective treatment for COVID-19 after early trials showed some promise.
At the end of October, Gilead cut its 2020 revenue forecast, citing lower-than-expected demand and difficulty in predicting sales of remdesivir, which is also known as Veklury.
The antiviral is one of only two medicines authorised to treat COVID-19 patients across the world but a large WHO-led trial known as the Solidarity Trial showed last month that it had little or no effect on 28-day mortality or length of hospital stays for COVID-19 patients.
The medication was one of the drugs used to treat US President Donald Trump's coronavirus infection and had been shown in previous studies to have cut time to recovery. It is authorised or approved for use as a COVID-19 treatment in more than 50 countries.
Gilead has questioned the Solidarity Trial's results.
"Veklury is recognised as a standard of care for the treatment of hospitalised patients with COVID-19 in guidelines from numerous credible national organisations," Gilead said.
The WHO's recommendation, which is not binding, is part of its so-called "living guidelines" project, designed to offer ongoing guidance for doctors to help them make clinical decisions about patients in fast-moving situations such as the COVID-19 pandemic.