By Stephanie Nebehay and John Miller
GENEVA/ZURICH (Reuters) – Health officials reviewing Gilead Science Inc’s
U.S. regulators appeared not to have done so when approving the drug this week, Soumya Swaminathan told a news conference.
The U.S. Food and Drug Administration on Thursday approved Gilead’s antiviral drug for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.
The FDA decision came a week after the release of the results of the World Health Organization’s Solidarity trial, which concluded remdesivir has little or no impact on a patient’s chances of surviving COVID-19.
Swaminathan said that the FDA does not appear to have taken the global health body’s study into account in its approval.
“We believe our results are very robust,” Swaminathan said, when asked about the FDA move. “We hope that people who are doing treatment guidelines in other countries, as well as regulators around the world, will take note of our study results, in addition to the other evidence.”
“Because you need to look at the global evidence for a drug, before you make decisions,” she added.
For the remdesivir arm of the WHO’s Solidarity trial, 2,743 patients were given the treatment, compared to 2,708 in the control group.
Gilead’s own study, of 1,062 participants, produced data indicating that the treatment cut COVID-19 recovery time by five days and helped reduce the risk of death in some patients who were getting oxygen.
The company, which has raised the possibility of bias in the “unblinded” WHO study because patients and their doctors were aware of which treatments were being used, got initial data showing that remdesivir failed the Solidarity trial in late September, the WHO has said.
The U.S. company said it told the FDA about initial Solidarity results.
“We have apprised FDA of the topline WHO Solidarity trial results and the draft manuscript”, submitted to a publication, it said. “However, at this time Gilead has not received the requested datasets from WHO for the Solidarity trial results.”
The FDA did not immediately comment on Swaminathan’s statement that the U.S. agency did not take Solidarity data into account in its approval.
The WHO also said on Friday that its formal guidelines on use of remdesivir for COVID-19 should be ready for release in three to four weeks, after a separate group within the United Nations health agency reviews data from the study.
An independent WHO panel will convene next week to look at all evidence of the effectiveness of Gilead’s drug, Janet Diaz, the WHO’s top official for clinical care responses, said.
“We would anticipate that the guidelines will be available within three to four weeks,” Diaz said. “What we’re doing now in the pandemic is to try to continue with that approach in a transparent and trustworthy way, but do it faster.”
(Reporting by John Miller, Stephanie Nebehay and Michael Shields; Additional reporting by Deena Beasley in Los Angeles; Writing by Peter Graff and John Miller; Editing by Kevin Liffey and Andrew Cawthorne)
