-- Expands Previous Authorization of Veklury
to Treat Hospitalized Patients with COVID-19 Regardless of Oxygen
Status --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S.
Food and Drug Administration (FDA) expanded the Emergency Use
Authorization (EUA) enabling use of the investigational antiviral
Veklury® (remdesivir) to treat all hospitalized patients with
COVID-19, in addition to the previous authorization for patients
hospitalized with severe COVID-19. The expanded EUA is based on
results from the Phase 3 SIMPLE trial evaluating Veklury in
hospitalized patients with moderate COVID-19 pneumonia, as well as
results from the National Institute of Allergy and Infectious
Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range
of disease severity.
“With the growing understanding of the utility of Veklury to
help improve outcomes for a range of patients with COVID-19, we
welcome the FDA’s decision to expand emergency use authorization,”
said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead
Sciences. “As we learn more about COVID-19 and we further establish
the efficacy and safety profile of Veklury, we see benefit to
making the drug available to patients at earlier stages of the
disease. Today’s action by the FDA enables physicians to consider a
broader range of eligible patients to potentially receive
Veklury.”
Results from the Phase 3 SIMPLE study were published in the
Journal of the American Medical Association (JAMA) on August 21,
2020 and confirm top-line results previously announced on June 1,
2020. The primary endpoint evaluated patients at Day 11 on a
7-point ordinal scale and found patients randomized to a 5-day
course of Veklury plus standard of care were 65 percent more likely
to have an improvement in clinical status compared with those
randomized to standard of care alone (OR, 1.65; 95% confidence
interval, 1.09-2.48; p=0.017). For patients in the 10-day Veklury
group, the improvement in clinical status at Day 11 was not
statistically different compared with the standard of care group
(OR, 1.31; 95% confidence interval, 0.88-1.95; p=0.183).
“As our understanding of the spectrum of SARS-CoV-2 infection
and the presentations and severity of COVID-19 continues to evolve,
these results and the expanded EUA represent a new, important step
that streamlines bedside prescribing of remdesivir without having
to wait for patients to worsen clinically,” said Francisco Marty,
MD, an infectious diseases physician at Brigham and Women’s
Hospital, and associate professor of medicine at Harvard Medical
School. “These study results show that patients with moderate
COVID-19 disease may also benefit from a 5-day treatment course of
remdesivir.”
The data published in JAMA demonstrate that Veklury was
generally well-tolerated in both the 5-day and 10-day treatment
groups. The most commonly reported adverse events in the 5-day,
10-day, and standard of care groups, respectively, were nausea (10%
vs 9% vs 3%), diarrhea (6% vs 5% vs 7%), hypokalemia (5% vs 7% vs
2%), and headache (5% vs 5% vs 3%). All-cause mortality at Day 28
was ≤ 2% in all treatment groups.
Please see below for additional important warnings and
information about the authorized use of Veklury in the United
States. In the United States, Veklury is an investigational drug
that has not been approved by the FDA, and the safety and efficacy
of Veklury for the treatment of COVID-19 have not been
established.
About the SIMPLE Trials
Gilead initiated two randomized, open-label, multi-center
international Phase 3 clinical trials for Veklury, the SIMPLE
studies, in countries with a high prevalence of COVID-19
infections.
The first SIMPLE trial is evaluating the safety and efficacy of
5-day and 10-day dosing durations of Veklury administered
intravenously in hospitalized patients with severe manifestations
of COVID-19. The initial phase of the study randomized 397 patients
in a 1:1 ratio to receive either a 5-day or a 10-day treatment
course of Veklury in addition to standard of care. Moderate disease
was defined in the study as any radiographic evidence of pulmonary
infiltrates and oxygen saturation >94% on room air. An expansion
phase of the study was added to enroll up to 5,600 additional
patients, including those on mechanical ventilation.
The second SIMPLE trial is evaluating the safety and efficacy of
5-day and 10-day dosing durations of Veklury administered
intravenously in hospitalized patients with moderate manifestations
of COVID-19, compared with standard of care. The initial phase of
the study randomized 600 patients in a 1:1:1 ratio to receive
either a 5-day or a 10-day treatment course of Veklury in addition
to standard of care, compared with standard of care alone. An
expansion phase of the study was added to enroll up to 1,000
additional patients with moderate disease.
About Veklury
(remdesivir)
Veklury is an investigational nucleotide analog with
broad-spectrum antiviral activity both in vitro and in vivo in
animal models against multiple emerging viral pathogens. Multiple
ongoing international Phase 3 clinical trials are evaluating the
safety and efficacy of Veklury for the treatment of SARS-CoV-2
infection, the virus that causes COVID-19, in different patient
populations, formulations, and in combination with other
therapies.
Important Information about Veklury in
the United States
In the United States, Veklury (remdesivir) is authorized for use
under an Emergency Use Authorization (EUA) only for the treatment
of hospitalized adult and pediatric patients with suspected or
laboratory-confirmed COVID-19. Veklury must be administered via
intravenous (IV) infusion and is supplied two ways: Veklury
(remdesivir) for injection, 100 mg, lyophilized powder, or Veklury
(remdesivir) injection, 100 mg/20 mL (5 mg/mL), concentrated
solution.
Veklury is an investigational drug that has not been approved by
the FDA for any use, and the safety and efficacy of Veklury for the
treatment of COVID-19 have not been established. This authorization
is temporary and may be revoked, and does not take the place of the
formal new drug application submission, review and approval
process. For information about the authorized use of Veklury and
mandatory requirements of the EUA in the U.S., please review the
Fact Sheets and FDA Letter of Authorization available at
www.gilead.com/remdesivir.
There are limited clinical data available for Veklury. Serious
and unexpected adverse events may occur that have not been
previously reported with Veklury use. Hypersensitivity reactions,
including infusion-related and anaphylactic reactions, have been
observed during and following administration of Veklury. The use of
Veklury is contraindicated in patients with known hypersensitivity
to Veklury. Transaminase elevations have been observed in healthy
volunteers and patients with COVID-19 in clinical trials who
received Veklury. Patients should have appropriate clinical and
laboratory monitoring to aid in early detection of any potential
adverse events. Monitor renal and hepatic function prior to
initiating and daily during therapy with Veklury; additionally
monitor serum chemistries and hematology daily during therapy. Do
not initiate Veklury in patients with ALT ≥5x ULN or with an eGFR
<30 mL/min. The decision to continue or discontinue Veklury
therapy after development of an adverse event should be made based
on the clinical risk/benefit assessment for the individual
patient.
Due to a risk of reduced antiviral activity, coadministration of
Veklury and chloroquine phosphate or hydroxychloroquine sulfate is
not recommended.
Healthcare providers and/or their designee are responsible for
mandatory FDA MedWatch reporting of all medication errors and
serious adverse events or deaths occurring during Veklury treatment
and considered to be potentially attributable to Veklury. These
events must be reported within 7 calendar days from the onset of
the event. MedWatch adverse event reports can be submitted to FDA
online at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City,
California.
For more information on Gilead’s response to the coronavirus
outbreak please visit the company’s dedicated page:
https://www.gilead.com/purpose/advancing-global-health/covid-19.
Forward-Looking
Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors. Veklury
is an investigational drug that has not been approved by the FDA
for any use, and it is not yet known if Veklury is safe or
effective for the treatment of COVID-19. There is the possibility
of unfavorable results from ongoing and additional clinical trials
involving Veklury and the possibility that Gilead and other parties
may be unable to complete one or more of such trials in the
currently anticipated timelines or at all. Further, it is possible
that Gilead may make a strategic decision to discontinue
development of Veklury or that FDA and other regulatory agencies
may not approve Veklury, and any marketing approvals, if granted,
may have significant limitations on its use. As a result, Veklury
may never be successfully commercialized. These risks,
uncertainties and other factors could cause actual results to
differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2020, as filed with the U.S. Securities and Exchange
Commission. All forward-looking statements are based on information
currently available to Gilead, and Gilead assumes no obligation to
update any such forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20200828005370/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Amy Flood, Media (650) 522-5643
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