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GENEVA: Health officials reviewing Gilead’s remdesivir against COVID-19 should consider all tests, including a trial in which the drug failed, before giving the green light, said on Friday (October 23) the chief scientist of the The OMS.
US regulators appeared not to have done so when they approved the drug this week, Soumya Swaminathan said at a news conference.
The US Food and Drug Administration approved Gilead’s antiviral drug for the treatment of hospitalized patients with COVID-19 on Thursday, making it the first and only drug approved for the disease in the United States.
The FDA’s decision came a week after the publication of the results of the World Health Organization’s Solidarity trial, which concluded that remdesivir has little or no impact on a patient’s chances of surviving COVID-19.
Swaminathan said the FDA does not appear to have considered the world health body study in its approval.
“We think our results are very strong,” Swaminathan said, when asked about the FDA move. “We hope that people who are following treatment guidelines in other countries, as well as regulators around the world, will take note of the results of our study, in addition to the other evidence.”
“Because you need to look at the global evidence for a drug before making decisions,” he added.
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For the remdesivir group of the WHO Solidarity trial, 2,743 patients were treated, compared with 2,708 in the control group.
Gilead’s own study of 1,062 participants produced data indicating that the treatment reduced the recovery time from COVID-19 by five days and helped reduce the risk of death in some patients who were receiving oxygen.
The company, which has raised the possibility of bias in the WHO “unblinded” study because patients and their doctors knew what treatments were being used, obtained initial data showing that remdesivir failed in the Solidarity trial in late September. said the WHO.
The US company said it informed the FDA about the initial results of Solidarity.
“We have informed the FDA of the main results of the WHO Solidarity trial and the draft manuscript,” which was sent for publication, he said. “However, at this time Gilead has not received the requested data sets from WHO for the results of the Solidarity trial.”
READ: WHO study says remdesivir did not reduce hospital stay or mortality in COVID-19 patients
The FDA did not immediately comment on Swaminathan’s statement that the US agency did not take Solidaridad’s data into account in its approval.
The WHO also said Friday that its formal guidelines on the use of remdesivir for COVID-19 should be ready for publication in three to four weeks, after a separate group within the United Nations health agency reviews the data. of the study.
An independent WHO panel will meet next week to review all the evidence for the efficacy of Gilead’s drug, said Janet Diaz, the WHO’s chief official for clinical care responses.
“We anticipate that the guidelines will be available within three to four weeks,” Diaz said. “What we’re doing now in the pandemic is trying to continue that approach in a transparent and trustworthy way, but do it faster.”
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