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The US Food and Drug Administration (FDA) has approved the first drug to treat Covid-19: remdesivir, an antiviral medicine given through an IV for patients needing hospitalization.
The drug, which California-based Gilead Sciences Inc is calling Veklury, cut the time to recovery from 15 days to 10 on average in a large study led by the US National Institutes of Health.
It had been authorized for use on an emergency basis since spring, and now has become the first drug to win full US approval for treating Covid-19.
Gilead says Veklury is approved for people at least 12 years old and weighing at least 88lb (40kg) who need hospitalization for their coronavirus infection. It works by inhibiting a substance the virus uses to make copies of itself.
The move comes despite a more critical study released by the World Health Organization (WHO) last week that found that the antiviral drug did not help cut deaths of hospitalized Covid-19 patients. Some doctors said the WHO study was not definitive because of its methodology. It took data from hundreds of hospitals in 30 countries.
Separately, the FDA may have to decide by the year’s end whether to allow use of the first vaccines against the virus. Multiple vaccines are being studied using different technologies that each have pros and cons.
It’s a critical moment in the FDA’s 114-year history. The US government has spent billions to race a vaccine through a research process that usually takes years, and the FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.
Source: The Guardian
Keyword: US regulators approve first drug to treat Covid-19 | Coronavirus