Covid-19 Drug Remdesivir Fully Approved by FDA
October 22 2020 - 6:39PM
Dow Jones News
By Joseph Walker
The U.S. Food and Drug Administration has granted a full final
approval to Gilead Sciences Inc.'s remdesivir, making it the first
Covid-19 treatment deemed safe and effective by the regulator, the
company said Thursday.
Remdesivir has been widely used to treat hospitalized Covid-19
patients since May, when it received a provisional clearance from
regulators known as an emergency-use authorization. Emergency
authorizations are used to quickly get experimental drugs to
patients without other treatment options in the event of biological
and other threats.
Under the full-fledged approval, remdesivir is greenlighted to
treat patients ages 12 years and older who require hospitalization
for Covid-19. The FDA said remdesivir, which is sold under the
brand-name Veklury, should be given via daily intravenous infusions
for five days in most patients or 10 days among those on
ventilators or life support.
It has shown modest effectiveness in clinical trials but has
become the standard of care in hospitalized patients because of the
dearth of other treatments.
In early October, President Trump was treated with remdesivir
along with an experimental antibody treatment made by Regeneron
Pharmaceuticals Inc.
Gilead had originally studied remdesivir as an Ebola treatment,
but it proved less effective than other medicines treating that
disease. When the new coronavirus was identified in January, the
company was already working with academic researchers to study its
potential in treating other coronaviruses, such as Middle East
respiratory syndrome, or MERS. The company was soon helping supply
clinical trials in China and eventually in the U.S.
"It is incredible to be in the position today, less than one
year since the earliest case reports of the disease now known as
Covid-19, of having an FDA-approved treatment in the U.S. that is
available for all appropriate patients in need," Gilead Chief
Executive Daniel O'Day said in a statement.
At the same time it issued a full approval, the FDA authorized
remdesivir's emergency use in patients younger than 12 years.
Clinical trials testing the drug in those younger patients are
ongoing.
The FDA approval is based primarily on a U.S. trial of 1,062
patients that found remdesivir sped up patients' recovery time by
five days compared with placebo. The study failed to show a
statistically significant benefit in reducing deaths, however.
Other studies have failed to show a clinically meaningful
benefit from taking remdesivir compared with standard treatment or
placebo.
Analysts on average project global remdesivir sales of $2.3
billion in 2020 and $2.1 billion in 2021, according to FactSet.
"The formal FDA approval doesn't change our estimates or outlook
for remdesivir given it has already been branded standard-of-care
prior to formal approval," said Steven Seedhouse, a Raymond James
analyst, in a note to clients.
Gilead shares rose 3.8% in after-hours trading following the
approval.
(END) Dow Jones Newswires
October 22, 2020 18:24 ET (22:24 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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