“The … panel found a lack of evidence that remdesivir improved outcomes that matter to patients such as reduced mortality, need for mechanical ventilation, time to clinical improvement, and others,” the guideline said.
The news is another setback for the medicine, which took worldwide recognition as a potentially effective treatment for COVID-19 in the summer after early trials revealed some encouragement.
At the end of October, Gilead cut its 2020 revenue forecast, citing lower-than-expected requests and complexity in predicting sales of ramdev sivir.
The antiviral is one of only two medicines currently approved to treat COVID-19 victims across the world, but a large WHO-led trial known as the Solidarity Trial revealed last month that it had almost no effect on 28-day mortality or the time period of hospital stays for COVID-19 patients.
The medication was one of the drugs used to treat the U.S. President Donald Trump’s COVIDE-19 infection and had been presented in previous studies to have shortened recovery time. It is authorized or approved for use as a COVID-19 treatment in at least 50 countries.
Gilead has doubted the Solidarity Trial’s results.
“Veklury is recognized as a standard of care for the treatment of hospitalized patients with COVID-19 in guidelines from numerous credible national organizations,” Gilead said in a statement, referring to the medicine's brand name.
“We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Velury as the first and only approved antiviral treatment for patients with COVID-19.”
The WHO’s Guideline Development Group (GDG) panel said its recommendation was based on an evidence review that included data from four international randomized trials involving more than 7,000 patients hospitalized with COVID-19.
After examining the evidence, the panel said, it settled that remade sivir, which has to be given intravenously and is therefore costly and complex to administer, has no significant effect on death rates or other relevant outcomes for patients.
“Especially given the costs and resource implications associated with remdesivir …the panel felt the responsibility should be on demonstrating evidence of efficacy, which is not established by the currently available data,” it added.
The WHO’s recommendation, which is not obligatory, is part of its so-called “living guidelines” project, intended to offer direction for doctors to help them make clinical judgments about patients in fast-moving situations such as the COVID-19 pandemic. The guidelines can be updated and reviewed as new evidence and information emerges.