-- Veklury Is First and Only FDA-Approved
Treatment for COVID-19 in the United States --
-- Veklury Shortened Time to Recovery By
Five Days in Hospitalized COVID-19 Patients --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
U.S. Food and Drug Administration (FDA) has approved the antiviral
drug Veklury® (remdesivir) for the treatment of patients with
COVID-19 requiring hospitalization. As an antiviral drug, Veklury
works to stop replication of SARS-CoV-2, the virus that causes
COVID-19. Previously authorized by the FDA for emergency use to
treat COVID-19, Veklury is now the first and only approved COVID-19
treatment in the United States. The drug is now widely available in
hospitals across the country, following early investments to
rapidly expand manufacturing capacity to increase supply.
In the United States, Veklury is indicated for adults and
pediatric patients (12 years of age and older and weighing at least
40 kg) for the treatment of COVID-19 requiring hospitalization.
Veklury should only be administered in a hospital or in a
healthcare setting capable of providing acute care comparable to
inpatient hospital care. Veklury is contraindicated in patients who
are allergic to Veklury or any of its components; please see below
for additional Important Safety Information for Veklury.
This approval is based on three randomized controlled trials
including the recently published, final results of the National
Institute of Allergy and Infectious Diseases’ (NIAID) double blind,
placebo-controlled Phase 3 ACTT-1 trial, which showed that
treatment with Veklury resulted in clinically meaningful
improvements across multiple outcome assessments compared with
placebo in hospitalized patients with COVID-19. Based on the
strength of these data, Veklury has become a standard of care for
the treatment of COVID-19 in hospitalized patients.
“The approval of Veklury marks an important milestone in efforts
to help address the pandemic by offering an effective treatment
that helps patients recover faster and, in turn, helps preserve
scarce healthcare resources,” said Barry Zingman, MD, Professor of
Medicine at the Albert Einstein College of Medicine and Montefiore
Medical Center, New York. “The availability of a rigorously tested
treatment that can significantly speed recovery and offers other
benefits such as lower rates of progression to mechanical
ventilation, provides hospitalized patients and their families
important hope and offers healthcare providers a critical tool as
they care for patients in need.”
“Since the beginning of the COVID-19 pandemic, Gilead has worked
relentlessly to help find solutions to this global health crisis.
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,” said Daniel O’Day,
Chairman and Chief Executive Officer, Gilead Sciences. “The speed
and rigor with which Veklury has been developed and approved in the
U.S. reflect the shared commitment of Gilead, government agencies
and clinical trial investigators to advance well-tolerated,
effective treatment options for the fight against COVID-19. We will
continue to work at speed with the aim of enhancing patient
outcomes with Veklury to ensure all patients with COVID-19 have the
best chance at recovery.”
In the randomized, double-blind, placebo-controlled ACTT-1
trial, Veklury significantly improved time to recovery as compared
to placebo – by five days in the overall study population (10 vs.
15 days; rate ratio, 1.29; 95% CI, 1.12 to 1.49; p<0.001) and
seven days in patients who required oxygen support at baseline (11
vs. 18 days; rate ratio, 1.31; 95% CI, 1.12 to 1.52). As a
secondary endpoint, Veklury also reduced disease progression in
patients needing oxygen, resulting in a significantly lower
incidence of new mechanical ventilation or ECMO (13% vs. 23%; 95%
CI, -15 to -4). In the overall patient population, there was a
trend toward reduced mortality with Veklury compared with placebo
at Day 29 (11.4% vs. 15.2%, HR 0.73; 95% CI, 0.52 to 1.03).
Additional mortality data from a post-hoc analysis were published
in the New England Journal of Medicine on October 8, 2020.
The ACTT-1 trial results are complemented by results of two
Phase 3 open-label trials of Veklury conducted in adult patients
with severe and moderate COVID-19. The SIMPLE-Severe trial,
conducted in hospitalized patients who required supplemental oxygen
and who were not mechanically ventilated, found that a five-day or
a 10-day treatment course of Veklury achieved similar clinical
outcomes (odds ratio 0.75; 95% CI, 0.51 to 1.12). The
SIMPLE-Moderate trial, conducted in hospitalized patients who did
not require supplemental oxygen, showed statistically improved
clinical outcomes with a five-day treatment course of Veklury
compared with standard of care (odds ratio 1.65; 95% CI, 1.09 to
2.48; p=0.017). The odds of improvement in clinical status with the
10-day treatment course of Veklury versus standard of care were
also favorable, trending toward but not reaching statistical
significance (odds ratio 1.31; 95% CI, 0.88 to 1.95).
The incidence of adverse events associated with Veklury was
similar to placebo in the ACTT-1 trial. Rates of serious adverse
events (SAEs) were numerically higher in the placebo group compared
with the Veklury group. Treatment discontinuation, all-cause grade
3 and 4 adverse events (AEs) and laboratory abnormalities were
similar across groups. In the SIMPLE-Severe trial, the most common
adverse reactions occurring in at least 5% of subjects in either
the Veklury 5-day or 10-day group, respectively, were nausea (5% vs
3%), AST increased (3% vs 6%), and ALT increased (2% vs 7%). In the
SIMPLE-Moderate trial, the most common adverse reaction occurring
in at least 5% of subjects in the Veklury groups was nausea (7% in
the 5-day group, 4% in the 10-day group).
In parallel with the FDA approval of Veklury, the FDA also
issued a new Emergency Use Authorization (EUA) for the use of
Veklury to treat hospitalized pediatric patients under 12 years of
age weighing at least 3.5 kg or hospitalized pediatric patients
weighing 3.5 kg to less than 40 kg with suspected or laboratory
confirmed COVID-19 for whom use of an intravenous (IV) agent is
clinically appropriate. This authorization is temporary and may be
revoked, and does not take the place of the formal submission,
review and approval process for the use of Veklury in this patient
population. The use of Veklury in pediatric patients under 12 years
of age or weighing less than 40 kg has not been approved by FDA,
and the safety and efficacy of Veklury for this use has not been
established. For information about the authorized use of Veklury in
pediatric patients 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.
About the ACTT-1 Trial
The global, randomized, double-blind, placebo-controlled, Phase
3 clinical trial ACTT-1 (NTC04280705) sponsored by the National
Institute of Allergy and Infectious Diseases (NIAID) evaluated the
efficacy and safety of a 10-day treatment course of Veklury versus
placebo in 1,063 hospitalized adult patients with confirmed
SARS-CoV-2 infection and mild, moderate or severe COVID-19 who also
were receiving treatment with standard of care.
The primary outcome measure of ACTT-1 was time to recovery
within 29 days after randomization. Recovery was defined as
discharged from the hospital without limitations on activities,
discharged from the hospital with limitations on activities and/or
requiring home oxygen, or hospitalized but not requiring
supplemental oxygen and no longer requiring ongoing medical
care.
About the SIMPLE Trials
Gilead’s two open-label Phase 3 trials of Veklury were conducted
in countries with a high prevalence of COVID-19 infections and
included U.S. trial sites that serve diverse communities.
The SIMPLE-Severe trial (NCT04292899) was a randomized,
open-label multi-center study that evaluated the efficacy and
safety of five-day and 10-day dosing durations of Veklury plus
standard of care in 397 hospitalized adult patients with severe
COVID-19. Severe COVID-19 was defined as patients with confirmed
SARS-CoV-2 infection, an SpO2 of ≤94% on room air, and radiological
evidence of pneumonia. The primary endpoint was clinical status on
Day 14 assessed on a 7-point ordinal scale. Treatment with Veklury
was stopped in subjects who were discharged from the hospital prior
to completion of their protocol-defined duration of treatment.
The SIMPLE-Moderate trial (NCT04292730) was a randomized,
controlled, open-label multi-center study that evaluated the
efficacy and safety of five-day and 10-day dosing durations of
Veklury plus standard of care compared with standard of care alone
in 600 hospitalized adult patients with moderate COVID-19. Moderate
COVID-19 was defined as confirmed SARS-CoV-2 infection, SpO2
>94% and radiological evidence of pneumonia. The primary
endpoint was clinical status on Day 11 assessed on a 7-point
ordinal scale.
About Veklury
Veklury (remdesivir) is a nucleotide analog invented by Gilead,
building on more than a decade of the company’s antiviral research.
Veklury has broad-spectrum antiviral activity both in vitro and in
vivo in animal models against multiple emerging viral pathogens,
including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that
causes COVID-19.
Veklury has been approved or authorized for temporary use as a
COVID-19 treatment in approximately 50 countries worldwide. In our
continuing commitment to develop effective treatments for COVID-19,
multiple ongoing international Phase 3 clinical trials are
evaluating the safety and efficacy of Veklury for the treatment of
COVID-19, in different patient populations, formulations, and in
combination with other therapies.
As announced on October 1, 2020, Gilead is now meeting real-time
demand for Veklury in the United States and anticipates meeting
global demand for Veklury in October, even in the event of
potential future surges of COVID-19.
U.S. Important Safety Information for
Veklury
Contraindication
- VEKLURY is contraindicated in patients with a history of
clinically significant hypersensitivity reactions to VEKLURY or any
of its components.
Warnings and precautions
- Hypersensitivity, including infusion-related and anaphylactic
reactions: Hypersensitivity, including infusion-related and
anaphylactic reactions, has been observed during and following
administration of VEKLURY. Monitor patients under close medical
supervision for hypersensitivity reactions during and following
administration of VEKLURY. Symptoms may include hypotension,
hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea,
wheezing, angioedema, rash, nausea, diaphoresis, and shivering.
Slower infusion rates (maximum infusion time ≤120 minutes) can
potentially prevent these reactions. If a severe infusion-related
hypersensitivity reaction occurs, immediately discontinue VEKLURY
and initiate appropriate treatment (see Contraindications).
- Increased risk of transaminase elevations: Transaminase
elevations have been observed in healthy volunteers and in patients
with COVID-19 who received VEKLURY; these elevations have also been
reported as a clinical feature of COVID-19. Perform hepatic
laboratory testing in all patients (see Dosage and administration).
Consider discontinuing VEKLURY if ALT levels increase to >10x
ULN. Discontinue VEKLURY if ALT elevation is accompanied by signs
or symptoms of liver inflammation.
- Risk of reduced antiviral activity when coadministered with
chloroquine or hydroxychloroquine: Coadministration of VEKLURY with
chloroquine phosphate or hydroxychloroquine sulfate is not
recommended due to antagonism observed in cell culture, which may
lead to a decrease in antiviral activity of VEKLURY
Adverse reactions
- The most common adverse reaction (≥5% all grades) was
nausea.
- The most common lab abnormalities (≥5% all grades) were
increases in ALT and AST.
Drug interactions
- Drug interaction trials of VEKLURY and other concomitant
medications have not been conducted in humans.
Dosage and administration
- Dosage: For adults and pediatric patients ≥12 years old and
weighing ≥40 kg: 200 mg on Day 1, followed by once-daily
maintenance doses of 100 mg from Day 2 administered only via
intravenous infusion over 30 to 120 minutes.
- Treatment duration: For patients not requiring invasive
mechanical ventilation and/or extracorporeal membrane oxygenation
(ECMO): 5 days; may be extended up to 5 additional days (10 days
total) if clinical improvement is not observed. For patients
requiring invasive mechanical ventilation and/or ECMO: 10
days.
- Testing prior to and during treatment: Perform eGFR, hepatic
laboratory, and prothrombin time testing prior to initiating
VEKLURY and during use as clinically appropriate.
- Renal impairment: VEKLURY is not recommended in individuals
with eGFR <30 mL/min.
- Dose preparation and administration: See full Prescribing
Information.
Pregnancy and lactation
- Pregnancy: There are insufficient human data on the use of
VEKLURY during pregnancy. Pregnant women hospitalized with COVID-19
are at risk for serious morbidity and mortality. VEKLURY should be
used during pregnancy only if the potential benefit justifies the
potential risk for the mother and the fetus.
- Lactation: It is not known whether VEKLURY can pass into breast
milk. Breastfeeding individuals with COVID-19 should follow
practices according to clinical guidelines to avoid exposing the
infant to COVID-19.
U.S. Indication for
Veklury
VEKLURY is indicated for adults and pediatric patients (12 years
of age and older and weighing at least 40 kg) for the treatment of
COVID-19 requiring hospitalization. Veklury should only be
administered in a hospital or in a healthcare setting capable of
providing acute care comparable to inpatient hospital care.
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,
including the risk that Veklury may not be successfully
commercialized or that Gilead may be unable to effectively manage
the global supply and distribution of Veklury. There is also 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. 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.
U.S. full Prescribing Information for Veklury
is available at www.gilead.com.
For information on the emergency use of Veklury
in pediatric patients under 12 years of age or weighing less than
40 kg, please see the U.S. Emergency Use Authorization Fact Sheets
available at www.gilead.com/remdesivir.
Gilead, the Gilead logo and Veklury are
trademarks of Gilead Sciences, Inc. or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20201022006149/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Sonia Choi, Media (650) 425-5483
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