WHO says doctors should not use Gilead’s remidesivir by splitting with FDA

A laboratory technician shows the drug “Remdesivir” to treat coronavirus disease (COVID-19).

Amr Abdullah Dalash | Reuters

A World Health Organization panel on Thursday used Gilad Sciences’ antiviral drug rimadesivir to treat hospitalized patients in Covid-1 with it, saying there was currently no evidence that it survives or shortens recovery time. The opposite is in Bha. Regulatory guidance on the drug.

A panel of international experts advising the agency, the WHO Guideline Development Group, said its recommendation was based on new data comparing the effects of many drug treatments, including data from four international randomized trials of more than 7,000 hospitalized patients with the disease. .

“After a thorough review of this evidence, the WHO GDG expert panel, which includes experts from around the world, including four patients with Covid-1 had, concluded that rimadesivir had no significant effect on mortality or other significant outcomes for patients. , Such as “need for mechanical ventilation or time for clinical improvement,” the group wrote in a press release.

The recommendation was published in the British Medical Trade Journal BMJ in the UK on Friday

In an emailed statement, Gilead said Remedizvir was sent to the U.S. COVID-19 is recognized as a standard for the treatment of hospitalized patients under the guidance of numerous trusted national organizations, including the National Institutes of Health and Infectious Diseases Society of America, Japan. UK and Germany. “

Gilead – “Worldwide cases are increasing dramatically and it is disappointing that doctors will ignore the evidence at a time when veterinarians rely on vascular as the first and only approved antiviral treatment for Covid-1 patients in nearly 50 countries.” Spokesman Chris Ridley said in a statement.

Rikdesivir, under the Vacaluri brand name, is operated by IV in a hospital setting. Gilead said the drug should only be given in a hospital or in a health-care setting that can provide patients with intensive care relative to hospital care.

Most patients treated with rimadesivir receive a five-day course using six vials of the drug. The company is also developing an inhaled version of the drug, which will be powered by a nebulizer, a delivery device that can turn liquid drugs into mist.

A study funded by the National Institutes of Health earlier this year found that some patients admitted to the hospital in Kovid-19 had a modest reduction in recovery time. It was one of the drugs used to treat President Donald Trump, who tested positive for the virus last month.

On 22 Oct October, the Food and Drug Administration formally approved the drug for adult and pediatric patients 12 years and older who need to be hospitalized for Covid-19. He is now in the U.S. for treatment of coronavirus. Is the first and only drug to be recognized in India, infecting approximately 4.56.4 million people worldwide and killing approximately 1.4 million people.

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

Some medical experts note that data on the effectiveness of the drug have been mixed. In October, a study compiled by the WHO suggested that there was “little or no effect” on drug mortality in hospitalized patients. The study was performed on 11,266 patients in 405 hospitals in 30 countries, of which 2,750 were given rimadesivir.

Gilead has publicly questioned the findings of the WHO study, telling Reuters in October that other trials show that recovery time in treatment is cut short. Gilead told Reuters, “Ging filing (WHO) data appear inconsistent with peer-reviewed journals acknowledging the clinical benefits of remedesivir, along with much stronger evidence from several randomized, controlled studies.”

The WHO panel acknowledged that the evidence so far did not prove that remedesivir was “of no use.”

But given the potential for harm as well as the high cost and resources required to handle the drug, it is a “reasonable recommendation.” The group said it supports continued enrollment in drug evaluation tests.