Previously, the use of Veklury, a Gilead Sciences Inc. drug, was limited to those requiring hospitalization.
A new, wearable device may help alert you if you are exposed to COVID-19. Researchers at the Yale School of Public Health developed an easy-to-clip-on device that can help detect low levels of SARS-COV-2 and subsequently whether a person has been exposed.
The agency has expanded the approved indication for Veklury to include its use in adults and pediatric patients 12 years and older – and weighing at least 88 pounds – with positive results of direct SARS-CoV-2 viral testing and who are not hospitalized, have mild-to-moderate COVID-19 and are at high risk for progression to severe disease.
"The main outcome measured in the trial was whether a patient was hospitalized for any COVID-19 related reason or died from any reason within 28 days of treatment. Overall, two of 279 patients who received Veklury required COVID-19 related hospitalization compared to 15 of 283 patients who received a placebo . There were no deaths in either group," the FDA said.
"Remdesivir has now helped to treat more than 10 million people around the world with COVID-19 and continues to play a key role in helping to reduce the burden of the pandemic. Based on the most recent data, we now understand that remdesivir is also effective in the early stages of COVID-19 infection, in addition to helping patients who are hospitalized with the disease," Daniel O’Day, the CEO of Gilead Sciences, said in a separate statement.
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