Remdesivir Becomes First Drug Approved By FDA To Treat Coronavirus
Gilead's antiviral drug has been given to some people with COVID-19, including President Donald Trump, under emergency use authorization until now. It has been shown to help shorten recovery times of some hospitalized patients.
USA Today:
FDA Approves Remdesivir As Treatment For COVID-19 Hospital Patients
The Food and Drug Administration (FDA) on Thursday approved the antiviral drug remdesivir as a treatment for patients with COVID-19 who require hospitalization. Given through an IV, remdesivir works to stop replication of SARS-CoV-2, the virus that causes COVID-19, according to the drug's manufacturer, California-based Gilead Sciences, Inc. Previously authorized by the FDA for emergency use to treat COVID-19, the drug is now the first and only approved COVID-19 treatment in the United States, Gilead said in a release. (Rice, 10/22)
AP:
FDA Approves First COVID-19 Drug: Antiviral Remdesivir
The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health. It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. President Donald Trump received it when he was sickened earlier this month. (Marchione, 10/22)
The New York Times:
F.D.A. Approves First Drug For Treating Coronavirus Patients
The F.D.A. said the antiviral drug had been approved for adults and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) who require hospitalization for Covid-19, the disease caused by the coronavirus, which has killed more than 220,000 people in the United States. ... The drug does not prevent deaths in Covid-19 patients. The formal approval now granted by the F.D.A. indicates that the drug cleared more rigorous regulatory hurdles involving a more thorough review of clinical data and manufacturing quality since it was given emergency authorization in May. (10/22)
Atlanta Journal-Constitution:
Coronavirus Drug Gets FDA Approval
Previous reporting by the AJC said the average cost for a five-day regimen of the drug was $3,120 for patients who had private insurance. Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income and other factors. (Lee, 10/22)
