WHO tells doctors not to use Gilead’s remdesivir and splits with FDA

Lab technicians are showing the drug “remdesivir” for the treatment of coronavirus disease (COVID-19).

Amr Abdallah Dalsh | Reuters

A World Health Organization committee advised doctors not to use Gilead Sciences’ antiviral drug remdesivir as a treatment for patients admitted with Covid-19 on Thursday, and is currently improving survival and shortening recovery times. “There is no evidence” to do so, he said. Regulatory guidance on drugs.

The WHO Guideline Development Group, a panel of international experts providing advice to authorities, has recommended that the recommendations include data from four international randomized trials of more than 7,000 patients admitted to the disease. He said it was based on new data comparing the effects of several medications.

“After a thorough examination of this evidence, the WHO GDG Expert Panel, which includes experts from around the world, including four patients who developed covid-19, said that remdesivir was responsible for mortality and other important patient outcomes. We concluded that it had no significant effect. The need for time to mechanical artificial respiration or clinical improvement, “the group wrote in a press release.

The recommendation was published in the British medical journal The BMJ on Friday, UK.

Gilead said in an email statement that Remdesivir “American National Society of Hygiene and Infectious Diseases, Japan, United Kingdom and Germany.”

“WHO guidelines ignore this evidence as cases worldwide increase dramatically and physicians rely on Veklury as the first and only approved antiviral treatment for COVID-19 patients in approximately 50 countries. I’m disappointed that it looks like it’s doing, “Gilead spokesman Chris Ridley said in a statement.

Remdesivir under the Veklury brand name is administered in a hospital setting via IV. Gilliad states that the drug should only be given in a medical environment that can provide acute treatment comparable to hospital or inpatient treatment in the hospital.

The majority of patients treated with remdesivir take a 5-day course using 6 bottles. The company is also developing an inhaled version of the drug that is administered via a nebulizer, a delivery device that can turn the drug solution into a mist.

After a study funded by the National Institutes of Health found that recovery times for some patients admitted with Covid-19 were moderately shortened, the drug was a potentially effective treatment for coronavirus. It attracted worldwide attention as. It was one of the drugs used to treat President Donald Trump, who was virus-positive last month.

On October 22, the Food and Drug Administration officially approved a drug for adults and pediatric patients aged 12 and over who require hospitalization for Covid-19. It is currently the first and only drug approved in the United States to treat the coronavirus, infecting about 56.4 million people worldwide and killing about 1.4 million people.

Dr. Anthony Fauci, one of the country’s leading infectious disease specialists, praised the drug, saying it would set a “new standard of care” for Covid-19 patients.

Some healthcare professionals point out that there is a mix of data on drug efficacy. In October, a WHO-coordinated study showed that the drug “had little or no effect” on inpatient mortality. The study was conducted in 405 hospitals in 30 countries with 11,266 patients, and 2,750 received remdesivir.

Gilead publicly questioned the results of the WHO study and told Reuters in October that other trials showed that treatment reduced recovery time. “The new (WHO) data are inconsistent and there is more solid evidence from multiple randomized controlled trials published in peer-reviewed journals examining the clinical benefits of remdesivir,” Gilead told Reuters.

The WHO Commission has admitted that the evidence so far does not prove that remdesivir “does not benefit”.

However, given the potential for harm and the high cost and resources required to administer the drug, he added that it was a “reasonable recommendation.” The group said it would support continued enrollment in trials evaluating the drug.

WHO tells doctors not to use Gilead’s remdesivir and splits with FDA

Source link WHO tells doctors not to use Gilead’s remdesivir and splits with FDA

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