[ad_1]
The World Health Organization (WHO) has advised against using Gilead’s remdesivir in patients hospitalized with coronavirus, weeks after the drug was found to have “little or no effect” in the trial of the agency’s multi-country solidarity.
The WHO’s Guideline Development Group (PDG) on Friday released the updated guidelines and said they were based on evidence that the expensive intravenous drug had no significant effect on blood levels. mortality. The drug is to be administered for five to 10 days intravenously and was the first to gain FDA approval for COVID-19 treatment.
“The … panel found a lack of evidence that remdesivir improves outcomes that matter to patients,” GDP said on Friday, according to Reuters. “Importantly, given the costs and resource implications associated with remdesivir… the expert panel felt that the onus should be to demonstrate efficacy, which is not established by the data currently available.”
4 CORONAVIRUS TREATMENTS, INCLUDING REMDESIVIR, HYDROXYCHLOROQUINE, FLOP IN WHO’S LARGE STUDY
The antiviral, known as Veklury, was first approved by the FDA to treat coronavirus patients in October and was part of the regimen administered to President Donald Trump upon his diagnosis. Gilead had published the results of a Phase 3 ACTT-1 trial shortly before approval, which “demonstrated faster recovery times” in adults hospitalized with mild to severe coronavirus cases.
As such, the FDA has approved it for use in adult and pediatric patients 12 years of age and older weighing at least 88 pounds for the treatment of COVID-19 requiring hospitalization.
PFIZER MUST SUBMIT CORONAVIRUS VACCINE FOR EMERGENCY USE AUTHORIZATION: THIS IS WHAT IT MEANS
However, the WHO solidarity trial showed that the drug had little or no effect on 28-day mortality or length of hospital stay for patients with coronavirus. It was one of four tested in the trial, with the researchers concluding that “the main outcomes of mortality, initiation of ventilation, and length of hospital stay were clearly not reduced by any drug in the study. “.
The WHO findings on remdesivir are in contrast to an NIH-led study that found it shortened patients’ healing path by up to four days. These results were confirmed in a second study and led Gilead to question the WHO solidarity trial and the new guidelines.
CLICK HERE FOR FULL CORONAVIRUS COVERAGE
“Veklury is recognized as a standard of care for the treatment of hospital patients with COVID-19 in the guidelines of many credible national organizations,” the company said, according to Reuters. “The WHO guidelines appear to ignore this evidence at a time when cases are increasing dramatically around the world and doctors are counting on Veklury as the first and only approved antiviral treatment for patients with COVID-19.
The guidelines were released a day after the FDA granted emergency approval for a drug combo including remdesivir to treat hospital patients with coronavirus.
Kayla Rivas of Fox News contributed to this report.
[ad_2]
Source link