Gilead allows generic companies to manufacture the drug for supply to 127 low-income countries.
Geneva / Zurich:
Health officials reviewing Gilead Science Inc’s remdesivir for COVID-19 should examine all the evidence, including a failed trial, before giving it the nod, the chief scientist at the hospital said on Friday. ‘WHO.
U.S. regulators do not appear to have done so when approving the drug this week, Soumya Swaminathan said at a press conference.
The U.S. Food and Drug Administration on Thursday approved Gilead’s antiviral drug for the treatment of hospital patients 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 results of the World Health Organization’s Solidarity trial were published, which concluded that remdesivir had little or no impact on a patient’s chances of survival. to COVID-19.
The FDA said its approval was based on three trials, including a study of 1,062 patients by the National Institute of Allergy and Infectious Diseases, which found that remdesivir reduced hospital stays to 10 days from 15 days and helped reduce the risk of death in some patients receiving oxygen. The drug did not improve overall survival.
“Solidarity’s results do not refute these beneficial results for patients,” the FDA said in a statement posted on its website.
Remdesivir is also approved for the treatment of patients with severe COVID-19 in Japan, Taiwan, India, Singapore, United Arab Emirates and the European Union. Gilead allows generic companies to manufacture the drug for supply to 127 low-income countries.
“We think our results are very strong,” said WHO’s Swaminathan, when asked about the FDA decision. “We hope that people 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.”
For the remdesivir arm of the WHO Solidarity trial, 2,743 patients received treatment, compared to 2,708 in the control group.
Gilead, who raised the possibility of bias in the “unblinded” WHO study because patients and their doctors knew what treatments were being used, obtained initial data from the trial in late September, said WHO.
“We have informed the FDA of the main results of the WHO solidarity trial and draft manuscript” submitted for publication, the company said. “However, at this time, Gilead has not received the requested data sets from WHO for the results of the Solidarity trial.”
The WHO also said on Friday that its formal guidelines on the use of remdesivir for COVID-19 should be ready for release in three to four weeks, after a separate group within the Nations health agency United reviewed the study data.
An independent WHO panel will meet next week to review all evidence for the effectiveness of Gilead’s drug, said Janet Diaz, WHO’s senior official for clinical care responses.
“We anticipate that the guidelines will be available within three to four weeks,” Diaz said. “What we are doing now in the pandemic is to try to continue with this approach in a transparent and trustworthy manner, but do it more quickly.”
(This story was not edited by GalacticGaming staff and is auto-generated from a syndicated feed.)
