The World Health Organization (WHO) has warned health officials reviewing Gilead Science Inc’s GILD.O remdesivir against COVID-19 to consider all evidence, including a trial where the medicine failed, before giving its approval to the anti-viral drug.
While making the disclosure during a news conference, Chief Scientist at WHO, Soumya Swaminathan, said that the US regulators, the Food and Drug Administration (FDA), appeared not to have considered the evidence when approving the drug this week.
Nairametrics earlier reported that the US Food and Drug Administration on Thursday, granted full approval to 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 approval came days after a WHO study had discovered the remdesivir anti-viral drug had little or no effect on COVID-19 patients’ length of stay in the hospital or chances of survival. WHO said it failed to prevent deaths among patients.
Swaminathan said that the FDA did not appear to have taken the global health body’s study into account in its approval.
When asked about the FDA move during the news conference, Swaminathan said, “We believe our results are very robust. 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 5 days and helped reduce the risk of death in some patients who were getting oxygen.
The WHO said that 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. However, the U.S. company said that it had told the FDA about initial Solidarity 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 disclosed on Friday that its formal guidelines on the use of remdesivir for COVID-19 should be ready for release in 3 to 4 weeks after a separate group within the United Nations health agency would have reviewed data from the study.