TODAYS TOP HEADLINES
The Times, Gainesville, Georgia | gainesvilletimes.com
Weekend Edition - May 2-3, 2020 3A
FDA clears promising remdesivir drug
Regulators allow emergency use of treatment
that appears to shorten COVID-19 recovery
BY MATTHEW PERRONE
AND MARILYNN MARCHIONE
Associated Press
WASHINGTON — U.S. regulators on
Friday allowed emergency use of the first
drug that appears to help some COVID-
19 patients recover faster, a milestone in
the global search for effective therapies
against the coronavirus.
The Food and Drug Administration
cleared Gilead Science’s intravenous drug
for hospitalized patients with “severe dis
ease,” such as those experiencing breath
ing problems requiring supplemental
oxygen or ventilators.
President Donald Trump announced
the news at the White House alongside
Gilead CEO Daniel O’Day and Food and
Drug Administration Commissioner Ste
phen Hahn.
“This was lightning speed in terms of
getting something approved” said Hahn,
calling the drug “an important clinical
advance.”
The FDA acted after preliminary
results from a government-sponsored
study showed that the drug, remdesivir,
shortened the time to recovery by 31 %, or
about four days on average, for hospital
ized COVID-19 patients.
Those given the drug were able to leave
the hospital in 11 days on average vs. 15
days for the comparison group. The drug
may also help avert deaths, but that effect
is not yet large enough for scientists to
know for sure.
Dr. Sameer Khanijo, a critical care spe
cialist, said he wants to see additional stud
ies to clarify the drug’s benefit.
“I don’t think this is a cure yet, but I
think it’s starting to point us in the right
direction,” said Khanijo of North Shore
University Hospital in New York. “As a
society it’s nice to have something that will
help stem the tide of this disease.”
The FDA said preliminary results from
the government study warranted Friday’s
decision, though regulators acknowledged
“there is limited information known about
the safety and effectiveness of using
remdesivir.”
The drug’s side effects include potential
inflammation of the liver and problems
related to its infusion, which could lead
to nausea, vomiting, sweating and low
blood pressure. Information about dos
ing and potential safety issues will be pro
vided to physicians and patients, the FDA
said.
The National Institutes of Health’s Dr.
Anthony Fauci said Wednesday the drug
would become a new standard of care for
severely ill COVID-19 patients. Remde
sivir, which blocks an enzyme the virus
uses to copy its genetic material, has
not been tested on people with milder
illness.
The FDA authorized the drug under its
emergency powers to quickly speed the
availability of experimental drugs, tests
and other medical products during public
health crises.
In normal times the FDA requires
“substantial evidence” of a drug’s safety
and effectiveness, usually through one or
more large, rigorously controlled patient
studies. But during public health emergen
cies the agency can waive those standards
and require only that an experimental
treatment’s potential benefits outweigh its
risks.
Gilead has said it will donate its cur
rently available stock of the drug and is
ramping up production to make more.
It said the U.S. government would
coordinate distribution of remdesi
vir to parts of the country that need it
most.
No drugs are currently FDA-approved
for treating the coronavirus, and remdesi
vir will still need formal approval.
The FDA can convert the drug’s status to
full approval if Gilead or other research
ers provide additional data of remdesivir’s
safety and effectiveness.
“This is a very, very early stage so
you wouldn’t expect to have any sort of
full approval at this point,” said Cathy
Burgess, an attorney specializing in
FDA issues. “But obviously they want
to get this out to patients as quickly as
possible.”
The FDA previously allowed narrow use
of a malaria drug, hydroxychloroquine,
for hospitalized patients who were unable
to take part in ongoing studies of the medi
cation. Trump repeatedly promoted it as a
possible COVID-19 treatment, but no large
high-quality studies have shown the drug
works for that and it has significant safety
concerns.
The FDA warned doctors late last
month against prescribing the drug out
side of hospital or research settings, due to
risks of sometimes fatal heart side effects.
The agency made the announcements
after receiving new reports of injury
and death with the medication, which is
also used to treat lupus and rheumatoid
arthritis.
Two small studies published Friday add
to concerns about hydroxychloroquine.
Critically ill COVID-19 patients given
the pill-based drug were prone to heart
rhythm problems, and for many risks
mounted when it was combined with an
antibiotic, the studies found.
Gilead Sciences via Associated Press
In this March 2020 photo provided by Gilead Sciences, rubber stoppers are placed onto
filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United
States. Given through an IV, the medication is designed to interfere with an enzyme that
reproduces viral genetic material.
Welcome Home,
TERRY.
rV
Peach State
BANK&TRUST
GAINESVILLE’S ONE & ONLY COMMUNITY BANK
Member
fdic
r
Terry Evans
Executive Vice President
