– If Granted by the European Commission,
Veklury will become the First and Only Authorized Antiviral
Treatment Across All Stages of Renal Disease –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) granted a positive opinion for the
use of Veklury® (remdesivir) in COVID-19 patients with severe renal
impairment, including those on dialysis. The European Commission
(EC) will review the CHMP recommendation and, if adopted, Veklury
will become the first and only authorized antiviral COVID-19
treatment that can be used across all stages of renal disease.
In Europe, approximately 75 million people suffer from chronic
kidney disease (CKD). Patients with advanced CKD or end stage
kidney disease (ESKD) represent a population that is highly
vulnerable to COVID-19. They are at increased risk of morbidity and
mortality from COVID-19, with mortality rates as high as 21-25%,
and currently have limited treatment options that are safe and
“COVID-19 continues to pose a threat to the lives of vulnerable
individuals, including those with renal impairment,” said Anu
Osinusi, Vice President, Clinical Research for Hepatitis,
Respiratory and Emerging Viruses, Gilead Sciences. “Gilead’s
commitment to address the unmet needs of the most susceptible
populations remains a top priority. We are encouraged by today’s
CHMP opinion and will continue to invest in developing suitable
treatment options for populations at risk of severe disease.”
The clinical benefit of Veklury in hospitalized populations with
COVID-19 is supported by randomized controlled trials, real-world
evidence and meta-analyses, but its use has previously been
restricted among patients with severe renal impairment
(<30mL/min) due to insufficient data. This positive opinion for
use in people with severe renal impairment was based on results
from a Phase 1 Pharmacokinetic study (GS-US-540-9015), as well as
results from the Phase 3 REDPINE trial that evaluated the safety of
Veklury in patients hospitalized for COVID-19 with severe renal
impairment. No new safety signals were observed in either of the
“The positive opinion from the Committee helps validate the
safety profile of Veklury in people with severe renal impairment,”
said Prof. Dr. Tobias Welte, Professor of Pulmonary Medicine and
Director of the Department of Pulmonary and Infectious Diseases at
Hannover University School of Medicine. “Expanding the use of
Veklury in this population, which still has limited treatment
options, will help more people gain access to treatment for
In the European Economic Area (EEA), Veklury is the only
antiviral indicated for both the treatment of COVID-19 in adult and
adolescent patients who do not require supplemental oxygen and are
at increased risk of developing severe COVID-19, as well as adults,
adolescent and pediatric patients with pneumonia requiring
supplemental oxygen (low- or high-flow oxygen or other non-invasive
Gilead conducted a Phase 3, randomized, double-blind,
placebo-controlled parallel-group, multicenter study (REDPINE)
evaluating the efficacy and safety of Veklury in patients with
severely reduced kidney function who are hospitalized with
COVID-19. The trial enrolled 243 hospitalized adult participants
with confirmed COVID-19 and renal impairment who were randomized in
a 2:1 manner to receive Veklury (n=163) or placebo (n=80), in
addition to standard of care, and were stratified by ESKD,
high-flow oxygen requirement, and region (US vs. ex-US). The study
closed prematurely due to feasibility issues and was underpowered
to assess for efficacy because of lower-than-expected enrollment.
No new safety signals were observed in the study and no additional
adverse reactions to Veklury were identified in 163 hospitalized
patients with confirmed COVID-19 and acute kidney injury (AKI)
(n=60), CKD (eGFR <30 mL/minute) (n=44) or ESKD (eGFR <15
mL/minute) requiring hemodialysis (n=59) receiving Veklury for up
to 5 days.
Pharmacokinetic data were obtained from the REDPINE study, as
well as a Phase 1 open-label, parallel-group, single-dose study
(GS-US-540-9015). Given the observed PK and the absence of any new
safety signals associated with increased metabolite levels in
patients with severely reduced kidney function, no dose adjustment
of Veklury is recommended in patients with renal impairment,
including those on dialysis.
About Gilead’s COVID-19 Development
Veklury (remdesivir) is a nucleotide analog invented by Gilead,
building on more than a decade of the company’s antiviral research.
Veklury is the antiviral standard of care 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 plays an important role in reducing disease progression and
mortality across a spectrum of disease severity and enabling
patients to recover faster. 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 recent Omicron subvariants of concern,
including BQ.1.1 and XBB.
Veklury is approved in more than 50 countries worldwide. To
date, Veklury and generic remdesivir have been made available to
nearly 13 million patients around the world, including more than 8
million people in middle- and low-income countries through Gilead’s
voluntary licensing program.
There remains a significant need to develop new and effective
oral treatment options for people with COVID-19. Gilead is also
working to advance an investigational oral antiviral, obeldesivir,
for the treatment of COVID-19. Obeldesivir is a direct-acting
nucleoside inhibitor of the of the SARS-CoV-2 RNA-dependent RNA
polymerase (RdRp), a critical component that the virus uses to
replicate. Once metabolized, obeldesivir works in the same way as
Veklury to halt SARS-CoV-2 virus replication.
U.S. Indication for
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) 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 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.
- The most common adverse reaction (≥5% all grades) was
- The most common lab abnormalities (≥5% all grades) were
increases in ALT and AST.
- Drug interaction trials of Veklury and other concomitant
medications have not been conducted in humans.
Dosage and administration
- Administration should take place under conditions where
management of severe hypersensitivity reactions, such as
anaphylaxis, is possible.
- Treatment duration:
- For patients who are hospitalized, VEKLURY should be initiated
as soon as possible after diagnosis of symptomatic COVID-19.
- For patients who are hospitalized and do not require 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 up to 5 additional days, for
a total treatment duration of up to 10 days.
- For patients who are hospitalized and require invasive
mechanical ventilation and/or ECMO, the recommended total treatment
duration is 10 days.
- For patients who are not hospitalized, diagnosed with
mild-to-moderate COVID-19, and 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 for outpatient
- 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.
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,
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 and
obeldesivir; the possibility that Gilead may make a strategic
decision to discontinue development of Veklury and obeldesivir for
any indications that are currently under investigation, and as a
result, Veklury and obeldesivir may never be commercialized for
such indications; uncertainties relating to regulatory applications
and related filing and approval timelines, including the risk that
the European Commission may not approve Veklury for treatment of
COVID-19 patients with severe renal impairment, including those on
dialysis, without the need to test renal function or for dosing
adjustments in the currently anticipated timelines or at all; the
risk that any regulatory approvals, if granted, may be subject to
significant limitations on use, and the risk that physicians may
not see the benefits of prescribing Veklury such indication; 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 quarter ended March
31, 2023, 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
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
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