FDA Oks 1st COVID-19 Drug 10/23 06:26
U.S. regulators on Thursday approved the first drug to treat COVID-19:
remdesivir, an antiviral medicine given through an IV for patients needing
(AP) -- U.S. regulators on Thursday approved the first drug to treat
COVID-19: remdesivir, an antiviral medicine given through an IV for patients
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.
Veklury is approved for people at least 12 years old and weighing at least
88 pounds (40 kilograms) who need hospitalization for their coronavirus
infection. For patients younger than 12, the FDA will still allow the drug's
use in certain cases under its previous emergency authorization.
The drug works by inhibiting a substance the virus uses to make copies of
itself. Certain tests are required before starting patients on it. And the
label warns against using it with the malaria drug hydroxychloroquine, because
that can curb its effectiveness.
"We now have enough knowledge and a growing set of tools to help fight
COVID-19," Gilead's chief medical officer, Dr. Merdad Parsey, said in a
The drug is either approved or has temporary authorization in about 50
countries, he noted.
Its price has been controversial, given that no studies have found it
improves survival. Last week, a large study led by the World Health
Organization found the drug did not help hospitalized COVID-19 patients, but
that study did not include a placebo group and was less rigorous than previous
ones that found a benefit.
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.
Only one treatment -- steroids such as dexamethasone -- has been shown so
far to cut the risk of dying of COVID-19. The FDA also has given emergency
authorization to using the blood of survivors and two companies are currently
seeking similar authorization for experimental antibody drugs.