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The World Health Organization (WHO) recommended against using remdesivir from Gilead Sciences Inc. to treat hospitalized patients with Covid-19 less than a month after US regulators gave the drug quick approval.
“There is currently no evidence that it improves survival or the need for ventilation,” said a WHO-convened panel of experts developing Covid-19 treatment guidelines in the medical journal The BMJ.
The recommendation is a blow to Gilead’s drug, which was one of the first to offer a significant benefit in treating coronavirus patients after a study showed it shortened their recovery time. The antiviral has been widely used to treat Covid and was among the drugs President Donald Trump received when he was diagnosed with the disease in early October.
Experts made the recommendation after results from a WHO-sponsored worldwide trial called Solidarity found last month that remdesivir did not reduce deaths. They also reviewed data from three other trials and said the drug “has no significant effect” on the time it took patients to improve clinically.
The U.S. Food and Drug Administration (FDA) approved the drug a week later, basing its decision on a test conducted by the National Institutes of Health that showed remdesivir reduced the recovery time of hospitalized patients by five. days.
Gilead has questioned the results of the WHO trial, saying the agency has yet to release key data that will allow the company or others to assess the reliability of the interim results.
Multiple studies published in peer-reviewed journals have shown that remdesivir, also known by its brand name Veklury, is beneficial against the virus, particularly in improving recovery time, “which can free up limited hospital resources,” Gilead said in a press release on Thursday.
“We are disappointed that the WHO guidelines appear to ignore this evidence at a time when cases are increasing dramatically around the world and doctors are relying on Veklury as the first and only antiviral treatment approved for Covid-19 patients in approximately 50 countries, “according to the statement.
Despite disagreement with the WHO, the FDA said in its review of remdesivir that “no issues were identified that would benefit from discussion” by a panel of external advisers. The FDA often convenes such a panel before deciding whether to approve a drug in situations where questions arise from clinical trial data.
‘Relatively high cost’
The FDA originally granted emergency use authorization for remdesivir in May. Gilead applied for full FDA approval in August. The European Commission granted conditional authorization for the drug in July based on the US-led clinical trial.
Other countries have also approved remdesivir as a treatment for Covid. Japan’s Chief Cabinet Secretary Katsunobu Kato said on Friday there is no need for the nation, which gave its go-ahead in May, to review the approval of remdesivir at this time. Zhong Nanshan, a Chinese infectious disease expert, told a conference in Zhuhai that remdesivir is not “completely useless,” citing shorter hospital stays among mild patients in the United States.
The WHO experts wrote in The BMJ that their findings should not be construed to mean that remdesivir is ineffective, but that “there is no evidence based on currently available data that it improves patient-important outcomes.”
The limited evidence for the drug’s use was weighed against the “relatively high cost and resource implications associated with remdesivir,” which is administered intravenously, they said in a news release.
The FDA has previously been criticized for hastily authorizing an antimalarial drug, hydroxychloroquine, to treat Covid-19. Trump repeatedly touted the drug early in the pandemic, although medical evidence was lacking to back up his claims. Then the FDA revoked its authorization after hydroxychloroquine was shown not to fight the virus and was linked to harmful side effects. Bloomberg News
