Gilead has received the first US regulatory approval for a Covid-19 drug, as the Food and Drug Administration approved its antiviral remdesivir for patients hospitalised with the disease.
Shares in Gilead rose 4.2 per cent to $63.18 in after-hours trading after the FDA’s announcement. Remdesivir, now known by the brand name Veklury, was originally developed to treat Ebola.
The antiviral was already being used to treat patients under an emergency use authorisation. It was one of the drugs Donald Trump was given when the US president had Covid-19.
Trials have shown that remdesivir can speed up recovery but it has shown little effect on how likely patients are to survive.
Daniel O’Day, chief executive, said Gilead had worked “relentlessly” to help find solutions for the pandemic.
“The speed and rigour with which Veklury has been developed and approved in the US reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against Covid-19,” he said.
Stephen Hahn, the head of the FDA, said: “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic.”
Gilead has significantly expanded supply to meet demand for remdesivir, which has already been used as the standard of care across the US. The company recently signed a €1bn deal with the European Commission to supply 500,000 treatment courses.
Last week Gilead faced a setback when the World Health Organization’s Solidarity trial found the drug had little effect on mortality, reducing time in hospital or whether a patient ends up needing a ventilator. The trial of remdesivir included 2,750 patients.
A trial run by the US National Institutes of Health of more than 1,000 patients found it cut the time to recover from Covid-19 but also did not show that the drug helped to improve survival rates.
Gilead submitted the drug for approval in August, before the results of the Solidarity trial came out.
Some experts are concerned that the Solidarity trial shows that it is not effective. Andrew Hill, a researcher at the University of Liverpool’s department of pharmacology, said the FDA “did not include the majority of available data in their evaluation”.
Rochelle Walensky, the chief of the infectious diseases division at Massachusetts General Hospital and a professor at Harvard Medical School, said the preliminary data suggested “some modest benefit” which may be enough to approve remdesivir.
But she added that the “big picture benefit remains to be seen” given the Solidarity trial result. “It would have been disingenuous to not have included [the Solidarity data] in the package of materials if they indeed knew about the study,” she said.
Gilead said it told the FDA about the outline of the Solidarity trial results but had not received data it had requested from the trial. “While we cannot speak for what the FDA evaluated as part of their review, we know that they are aware of this ongoing trial and top-line results,” it said.
The approval is for adults and children over 12 years old who are in hospital but not on ventilators. The drug is given intravenously over five days. Gilead also said it had received an emergency use authorisation for remdesivir in children under 12 or weighing less than 40kg.
Barry Zingman, professor of medicine who oversaw a remdesivir trial at Montefiore Medical Center in New York, said the approval marked an “important milestone” that would help to improve patient results and preserve healthcare resources.
“The availability of a rigorously tested treatment that can significantly speed recovery and offers other benefits, such as lower rates of progression to mechanical ventilation, provides hospitalised patients and their families important hope and offers healthcare providers a critical tool as they care for patients in need,” he said.
Some scientists have expressed concerns that the FDA is under political pressure to show progress in the battle against Covid-19 ahead of the US presidential election that will be held in less than two weeks.
Vaccine makers have now said it will not be possible for them to meet FDA requirements until later in November at the earliest. Mr Trump has praised treatments for the disease, including Regeneron’s antibody treatment.
Additional reporting by Kiran Stacey in Washington
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