Gilead Sciences’ experimental coronavirus drug remdesivir will be made available to selected patients in the UK, health officials said on Tuesday, offering hope for those most severely affected by the disease.
Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said it was the first drug to receive approval — albeit in a limited and provisional form — to treat Covid-19, the disease caused by the new coronavirus, in the UK.
NHS coronavirus patients who are hospitalised will be able to receive the drug under the early access to medicines scheme. Treatment will be limited to those showing the greatest likelihood of benefit, the Department of Health said.
Patients eligible will have oxygen saturation levels of below 94 per cent, suspected or laboratory-confirmed Covid-19, and require supplemental oxygen, invasive ventilation or be attached to an ECMO machine, which adds oxygen to the blood, according to government documents. Doctors would ultimately decide who received the drug, the health department said.
“It is important to realise that this allows for legal access to an unlicensed medicine. The amount of evidence on remdesivir’s efficacy and safety is still limited and it’s possible it will not become licensed,” Prof Evans told the Science Media Centre.
“It is also not a recommendation for use, but it does allow clinicians to use the medicine outside one of the ongoing randomised trials without any fear of it being regarded as bad practice.”
The scheme is used in circumstances in which there is a clear medical need but no drugs have received marketing approval, and is not a substitute for the usual approval mechanism. This month, the US Food and Drug Administration allowed the drug for emergency use. Japan has approved it, too.
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Both Gilead and the health department declined to say how many UK patients would have access to the drug, which is being donated as part of Gilead’s effort to provide 1.5m vials free of charge worldwide. Rollout in the US has been hit by a lack of clear guidance.
Remdesivir was initially developed to treat viral conditions and was later evaluated for use against Ebola, but never approved to treat that disease.
Peer-reviewed evidence, released in The New England Journal of Medicine last week, shows the drug shortens recovery time for Covid-19 by about four days. Effects on mortality are unclear, though that study showed a positive trend.
Another peer-reviewed study, published last month in The Lancet, found no statistically significant benefit, though the company and investigators said it was statistically underpowered. The Financial Times first reported on those findings last month.
Trials, including in the UK, are continuing.
Gilead, which expects drug availability to be limited in the coming months, said it would continue to work closely with the UK government to enable broader access to patients.
The company’s New York-listed shares were down 0.6 per cent in early trading.
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