-- If Granted by the European Commission,
Veklury Will Become the First and Only Authorized Antiviral
Treatment for Pediatric Patients Under 12 Years of Age in the
European Union --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) adopted a positive opinion to
extend the indication of Veklury® (remdesivir) for the treatment of
pediatric patients (weighing at least 40 kg) who do not require
supplemental oxygen and are at increased risk of progressing to
severe COVID-19 and pediatric patients (4 weeks of age and older
and weighing at least 3 kg) with SARS-CoV-2 with pneumonia who
require supplemental oxygen (low- or high-flow oxygen or other
non-invasive ventilation at the start of treatment). The European
Commission (EC) will review the CHMP recommendation, and if
adopted, Veklury will be the only authorized COVID-19 treatment for
adolescents at high risk of progressing to severe COVID-19 and
pediatric patients with COVID-19 requiring supplemental oxygen.
“As the pandemic persists, there remains a critical need for
proven and effective antiviral therapies like Veklury that can
treat some of the most vulnerable in our society,” said Merdad
Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We are
proud of today’s CHMP opinion that represents a positive step
toward bridging the treatment gap for children and helping them
recover from COVID-19 more quickly.”
This positive opinion was based on results from the ongoing
CARAVAN Phase 2/3 study, which demonstrated Veklury was generally
well-tolerated among pediatric patients hospitalized with COVID-19,
with a high proportion of participants showing clinical improvement
and recovery, as well as data from trials in adults. Of the 53
pediatric patients enrolled in the CARAVAN study, no new safety
signals were apparent for patients treated with Veklury. Overall,
75% and 85% showed clinical improvement (≥2 point increase on an
ordinal scale) at Day 10 and last assessment, respectively, while
60% and 83% were discharged by Day 10 and Day 30, respectively. In
the study, 38 patients (72%) experienced adverse events (AEs), with
11 patients (21%) experiencing serious adverse events (SAEs) that
were determined not to be study-drug related, including three
participant deaths, which were consistent with the patients’
underlying medical conditions prior to study entry or with COVID-19
during hospitalization.
“As the COVID-19 pandemic evolves, it’s important to have
effective treatments with well-established safety profiles,
including for the vulnerable groups like children to help them
recover faster from COVID-19,” said Pablo Rojo, MD, PhD, Pediatric
Infectious Diseases Specialist of Hospital 12 de Octubre, Madrid,
Spain and Associate Professor of Complutense University, Madrid,
Spain. “Therefore, the medical community welcomes this CHMP
positive opinion for Veklury in pediatric patients and looks
forward to the EC decision.”
In the European Economic Area (EEA), Veklury is the only
antiviral indicated for both the treatment of COVID-19 in adult
patients who do not require supplemental oxygen and are at
increased risk of developing severe COVID-19, as well as adults and
adolescents (aged 12 to less than 18 years and weighing at least 40
kg) with pneumonia requiring supplemental oxygen (low- or high-flow
oxygen or other non-invasive ventilation at start of
treatment).
About Veklury
Veklury (remdesivir) is a nucleotide analog invented by Gilead,
building on more than a decade of the company’s antiviral research.
Veklury is a foundation for the treatment of hospitalized patients
with COVID-19 and is a recommended treatment for reducing disease
progression in non-hospitalized patients at high risk of disease
progression. Veklury has an established safety profile and minimal
known drug interactions in diverse populations. It can help reduce
disease progression across a spectrum of disease severity and
enable patients to recover faster, freeing up limited hospital
resources and saving healthcare systems money.
Veklury directly inhibits viral replication inside of the cell
by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro
analyses, Veklury retains antiviral activity against Omicron
subvariants BA.2.12.2, BA.4 and BA.5, which are currently the most
common circulating variants. Data continue to confirm that Veklury
retains antiviral activity against all Omicron subvariants analyzed
to date. Gilead continuously evaluates the activity of Veklury
against new SARS-CoV-2 variants of concern as they emerge around
the world.
Veklury is approved in more than 50 countries worldwide. To
date, Veklury and generic remdesivir have been made available to
more than 11 million patients around the world, including more than
7 million people in 127 middle- and low-income countries through
Gilead’s voluntary licensing program. These licenses currently
remain royalty-free, reflecting Gilead’s existing commitment to
enabling broad patient access to remdesivir.
U.S. Indication for
Veklury
Veklury® (remdesivir 100 mg for injection) is indicated for the
treatment of COVID-19 in adults and pediatric patients (≥28 days
old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral
testing, who are:
- Hospitalized, or
- Not hospitalized and have mild-to-moderate COVID-19 and are at
high risk for progression to severe COVID-19, including
hospitalization or death.
For more information, please see the U.S. full Prescribing
Information available at www.gilead.com.
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; most occurred within one hour. Monitor
patients during infusion and observe for at least one hour after
infusion is complete for signs and symptoms of hypersensitivity as
clinically appropriate. Symptoms may include hypotension,
hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea,
wheezing, angioedema, rash, nausea, diaphoresis, and shivering.
Slower infusion rates (maximum infusion time up to 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 based on data from cell culture experiments,
demonstrating potential antagonism, 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 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. For
pediatric patients ≥28 days and weighing ≥3 kg: 5 mg/kg on Day 1,
followed by once-daily maintenance doses of 2.5 mg/kg from Day 2,
administered only via intravenous infusion.
- Treatment duration:
- For hospitalized patients requiring invasive mechanical
ventilation and/or ECMO, the recommended total treatment duration
is 10 days. Veklury should be initiated as soon as possible after
diagnosis of symptomatic COVID-19.
- For hospitalized patients not requiring invasive mechanical
ventilation and/or ECMO, the recommended treatment duration is 5
days. If a patient does not demonstrate clinical improvement,
treatment may be extended for up to 5 additional days for a total
treatment duration of up to 10 days.
- For non-hospitalized patients diagnosed with mild-to-moderate
COVID-19 who are at high risk for progression to severe COVID-19,
including hospitalization or death, the recommended total treatment
duration is 3 days. Veklury should be initiated as soon as possible
after diagnosis of symptomatic COVID-19 and within 7 days of
symptom onset.
- 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:
- There are two different formulations of Veklury: Veklury for
injection (supplied as 100 mg lyophilized powder in vial) and
Veklury injection (supplied as 100 mg/20 mL [5 mg/mL] solution in
vial). The only approved dosage form for pediatric patients
weighing 3 kg to ≤40 kg is the lyophilized powder formulation; See
full Prescribing Information.
- Administration should take place only under conditions where
management of severe hypersensitivity reactions, such as
anaphylaxis, is possible.
Pregnancy and lactation
- Pregnancy: A pregnancy registry has been established. There are
insufficient human data on the use of Veklury during pregnancy.
COVID-19 is associated with adverse maternal and fetal outcomes,
including preeclampsia, eclampsia, preterm birth, premature rupture
of membranes, venous thromboembolic disease and fetal death.
- 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.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis and cancer. Gilead operates in more than 35
countries worldwide, with headquarters in Foster City,
California.
Forward-Looking
Statements
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 Gilead’s ability to effectively manage the supply and
distribution of Veklury; Gilead’s ability to initiate, progress or
complete clinical trials within currently anticipated timelines or
at all, and the possibility of unfavorable results from ongoing or
additional clinical trials, including those involving Veklury;
uncertainties relating to regulatory applications and related
filing and approval timelines, including the risk that the EC may
not grant marketing authorization for Veklury for treatment of
pediatric patients with COVID-19 in a timely manner or at all; the
risk that any regulatory approvals, if granted, may be subject to
significant limitations on use; and any assumptions underlying any
of the foregoing. These and other risks, uncertainties and factors
are described in detail in Gilead’s Quarterly Report on Form 10-Q
for the year ended June 30, 2022, as filed with the U.S. Securities
and Exchange Commission. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. All statements other
than statements of historical fact are statements that could be
deemed forward-looking statements. The reader is cautioned that any
such forward-looking statements are not guarantees of future
performance and involve risks and uncertainties and is cautioned
not to place undue reliance on these forward-looking statements.
All forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation and disclaims
any intent to update any such forward-looking statements.
U.S. full Prescribing Information for Veklury
is available at www.gilead.com.
Veklury, Gilead and the Gilead logo are
registered 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
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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