Gilead's remdesivir gets U.S. FDA approval for hospitalized COVID-19
patients
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[October 23, 2020]
By Deena Beasley
(Reuters) - The U.S. Food and Drug
Administration on Thursday approved Gilead Sciences Inc's antiviral drug
remdesivir for treating patients hospitalized with COVID-19, making it
the first and only drug approved for the disease in the United States.
Remdesivir, given intravenously, was one of the drugs used to treat U.S.
President Donald Trump during his bout with COVID-19.
The FDA's formal approval comes just hours before the president's final
debate with Democratic rival Joe Biden ahead of the Nov. 3 presidential
election.
Remdesivir has been available under an FDA emergency use authorization (EUA)
since May, after a study led by the National Institutes of Health showed
it reduced hospital stays by five days.
However, the World Health Organization (WHO) last week said its global
trial of COVID-19 therapies found that remdesivir did not have a
substantial effect on patients’ length of hospital stay or chances of
survival. That study has not been reviewed by outside experts.
Gilead has questioned the potential for bias in the WHO study, which was
not "blinded," meaning that patients and their doctors were aware of
which treatments were being used.
Remdesivir, which will be sold under the brand name Veklury, costs
$3,120 for a five-day treatment course, or $2,340 for government
purchasers such as the Department of Veterans Affairs. Shares of Gilead
rose 4.3% in after hours trading to $63.30.
Remdesivir has become the standard of care for patients hospitalized
with severe COVID-19 even though it has not been shown to improve
survival. The drug also has not been proven to significantly help
moderately-ill patients, and many doctors remain wary of using it in
patients with less severe illness.
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An ampule of Gilead Sciences COVID-19 antiviral remdesivir is
pictured during a news conference at the University Hospital
Eppendorf (UKE) in Hamburg, Germany, April 8, 2020, as the spread of
coronavirus disease (COVID-19) continues. Ulrich Perrey/Pool via
REUTERS
"The formal FDA approval doesn't change our (sales) estimates or
outlook for remdesivir given it has already been branded
standard-of-care prior to formal approval," Raymond James analyst
Steven Seedhouse said in a research note, calling the prescribing
guidelines and approval "pretty much a best case for Gilead," given
the WHO results questioning remdesivir's benefits.
Gilead said it is currently meeting demand for the drug in the
United States and anticipates meeting global demand by the end of
October.
The company said Veklury has regulatory approvals or temporary
authorizations in about 50 additional countries.
Also on Thursday, the FDA issued a new emergency use authorization
for remdesivir to treat hospitalized pediatric patients under age 12
who weigh enough to receive an intravenous drug.
Gilead said it is still working to understand the full potential of
remdesivir, in different settings and as part of combination therapy
approaches. The company is also developing an inhaled version of the
drug that might be used outside a hospital setting, if approved.
(Reporting by Vishwadha Chander in Bengaluru and Deena Beasley in
Los Angeles; Editing by Cynthia Osterman and Bill Berkrot)
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