Remedisvir has no significant effect, does not reduce mortality, WHO says

The FDA initially granted Remedisvir emergency use authority in May.

The World Health Organization has recommended hospitalized Kovid-19 patients less than a month’s treatment using Gilead Sciences Inc.’s Remedisvir, because US regulators quickly approved the drug.

“There is currently no evidence that this improves survival or the need for ventilation,” said a WHO panel developing treatment guidelines for COVID-19 in the BMJ Medical Journal.

This recommendation is a setback for Gilead’s medicine, which was initially thought to provide significant benefit in the treatment of patients with coronoviruses. Antivirals have been widely used to treat Kovid and the drugs were part of President Donald Trump when he was diagnosed with the disease in early October.

Experts recommended after the results of a WHO-sponsored global trial called Solidarity revealed last month that Remedisvir has not reduced the number of deaths. He also looked at data from three other trials, saying the drug had “no significant effect” in clinically improving patients.

The results of the solidarity were published on October 15. The US Food and Drug Administration approved the drug a week later, basing its decision on a test performed by the National Institutes of Health, saying inpatients had five at the time of hospitalization. Decreased by days.

Gilead questioned the WHO test results and said the agency still had not released key data that would allow the company or others to assess the reliability of the interim results.

Gilead said in a statement Thursday: “Numerous studies published in peer-reviewed journals have shown that valerie, also known by the brand name, is beneficial against the virus, particularly in improving recovery time. In.”

We are disappointed with the WHO guidelines as the first and only antiviral treatment approved for patients with Kovid-19 in nearly 50 countries, while the WHO guidelines ignore a period when cases are increasing dramatically in the world and Doctors rely on Vecleri. For the declaration.

Despite the differences with the WHO, the FDA said in its review of Remedisvir that “no issues were identified that would benefit from the discussion” by a panel of external advisers. The FDA typically informs such a panel before deciding whether or not to approve a drug in situations where clinical trial data raises questions.

‘Relatively high cost’

The FDA initially granted Remedisvir emergency use authority in May. Gilead sought full FDA approval in August. In July, the European Commission granted conditional authorization for the drug on the basis of a clinical trial led by the United States.

Other countries have also approved Remedisvir as a treatment for Kovid. Japanese chief cabinet secretary Katsunobu Kato said the nation was not needed on Friday, which granted approval in May to review the approval of Remediswear for now. Zhong Nanshan, a Chinese infectious disease expert, told a conference in Zhuhai that remidivir is not “completely unnecessary” due to the short hospital stay among mild patients in the United States.

WHO experts wrote in the BMJ that their results should not imply that Remedisvir is ineffective, but that “there is no evidence based on the data currently available that it improves critical patient outcomes. ”.

The limited evidence for drug use has been weighed down by the “relatively high costs and resources associated with Remedisvir,” given intraoperatively, he said in a press release.

The FDA has previously been criticized for clearing an antimalarial drug, hydroxychloroquine, as soon as possible for the treatment of Kovid-19. Trump repeatedly avoided the drug early in the epidemic, although medical evidence is lacking to back up his claims. The FDA then revoked its clearance because hydroxychloroquine was shown not to fight the virus and was associated with harmful side effects.

(Except for the title, this story was not edited by NDTV staff and posted from a syndicated feed.)

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