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The WHO is telling doctors not to use Remilezivir by Gilead, parting ways with the FDA

A laboratory technician shows the drug for the treatment of coronavirus disease (COVID-19) “Remdesivir”.

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A panel of the World Health Organization advised doctors on Thursday not to use the antiviral drug Gilead Sciences remdezivir as a treatment for patients hospitalized with Covid-1

9, saying there was currently no “evidence” that it improved survival or shortened recovery time. in stark contrast to US regulatory drug guidelines.

The WHO Guidelines Development Group, a group of international experts who provide advice to the agency, said its recommendation is based on new data comparing the effects of several drug treatments, including data from four international randomized trials involving more than 7,000 patients hospitalized with the disease.

“After reviewing this evidence, the WHO GDG expert group, which includes experts from around the world, including four patients who have covid-19, concluded that remdezivir had no significant effect on mortality or other important outcomes for patients, such as from mechanical ventilation or time for clinical improvement “, the group wrote in a press release.

The recommendation was published in the British medical trade magazine The BMJ on Friday in the UK

In an e-mail statement, Gilead said that remdezivir “is recognized as a standard of care for the treatment of hospitalized patients with COVID-19 in the direction of numerous reliable national organizations, including the US National Institutes of Health and Infectious Diseases in America, Japan, Britain and Germany. . “

“We are disappointed that the WHO guidelines ignore this evidence at a time when cases are increasing dramatically worldwide and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19 in approximately 50 countries,” said Gilead spokesman Chris Ridley. said in a statement.

Remdezivir, under the trademark Veklury, is administered in a hospital setting by IV. Gilead said the drug should only be given in a hospital or in healthcare facilities that can provide acute care comparable to a hospital.

The majority of patients treated with remdezivir received a five-day course of six vials of the drug. The company is also developing an inhaled version of the drug, which will be administered via a nebulizer, a delivery device that can turn liquid drugs into a mist.

The drug gained worldwide attention as a potentially effective treatment for coronavirus earlier in the year after a study funded by the National Institutes of Health found that it moderately reduced recovery time in some patients hospitalized with Covid-19. It was one of the drugs used to treat President Donald Trump, who tested positive for the virus last month.

On October 22, the Food and Drug Administration officially approved the drug for adult and pediatric patients 12 years of age and older who need to be hospitalized for Covid-19. It is currently the first and only drug approved in the United States to treat the coronavirus, which has infected approximately 56.4 million people worldwide and killed about 1.4 million.

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

Some medical experts note that data on the effectiveness of the drug are mixed. In October, a study coordinated by the WHO showed that the drug had “little or no effect” on mortality among hospitalized patients. The study was conducted in 405 hospitals in 30 countries in 11,266 patients, and 2,750 were given remdezivir.

Gilead has publicly questioned the findings of the WHO study, telling Reuters in October that other studies showed treatment had shortened recovery time. “Emerging data (WHO) appear to be incompatible, with more reliable evidence from a number of randomized, controlled trials published in peer-reviewed journals confirming the clinical benefit of remdezivir,” Gilead told Reuters.

The WHO panel acknowledged that the evidence so far did not prove that remdezivir was “useless”.

But added, given the possibility of harm, as well as the high cost and resources required to administer the drug, this is an “appropriate recommendation.” The group said it supported continued involvement in attempts to evaluate the drug.

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