The United States Food and Drug Administration on Thursday approved Gilead Sciences Inc.’s antiviral therapy remdesivir to treat COVID-19, even though a new and larger study led by the World Health Organization (WHO) last week concluded that the drug is not effective in treating patients with COVID-19. It does not help patients recover from COVID-19 and it does not reduce deaths, the study found.
The approval of remdesivir, sold under the brand name Veklury, will allow Gilead to market the drug and talk about its benefits to patients, doctors and nurses.
“Veklury is now the first and only approved Covid-19 treatment in the United States,” Gilead said in a statement.
Remdesivir got an emergency authorization from the FDA to treat COVID-19 in May following a smaller study that the drug cut the recovery time for hospitalized patients by 31 percent.
The FDA’s approval is based on the U.S. government-sponsored trial involving just about 1000 hospitalized coronavirus patients that found that those who received the drug recovered about five days faster than those who got a placebo.
However, the World Health Organization last week released preliminary results from a trial involving 11,266 COVID-19 patients in 30 countries who were treated with one of the four drug regiments, including remdesivir, and concluded that “the drug appeared to have little or no effect on hospitalized COVID-19” patient.
The study, posted on the journal preprint site medRxiv, measured the need for ventilation, the length of hospital stay and overall mortality.
The study found that remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.
The WHO said the progress achieved by the Solidarity Therapeutics Trial shows that large international trials are possible, even during a pandemic, and offer the promise of quickly and reliably answering critical public health questions concerning therapeutics.