-- Veklury is Now Recommended by the WHO for
Use in Both Non-Severe COVID-19 Patients at the Highest Risk of
Hospitalization and Patients with Severe COVID-19 --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced updates to
the World Health Organization’s (WHO) Therapeutics and COVID-19:
living guideline, which now conditionally recommends Veklury®
(remdesivir) for the treatment of patients with severe COVID-19 and
continues to conditionally recommend Veklury in those with
non-severe COVID-19 at the highest risk of hospitalization.
The WHO conditional recommendation for Veklury’s use in the
treatment of patients with severe COVID-19 is mainly driven by the
final results of the WHO-sponsored SOLIDARITY study, which showed a
statistically significant 17% lower relative risk of death or
progression to needing ventilation in patients requiring
supplemental oxygen at baseline, compared to standard of care (RR:
0.83; 95% CI: 0.75–0.93). Additionally, SOLIDARITY showed a
statistically significant 13% lower relative risk of mortality with
Veklury treatment for those patients hospitalized on supplemental
oxygen and not requiring mechanical ventilation, compared with
standard of care (RR: 0.87; 95% CI: 0.76–0.99). In the study,
Veklury had no significant effect on patients with COVID-19 who
were already being ventilated. These findings complement results
from the National Institute of Allergy and Infectious Diseases'
double-blind placebo-controlled ACTT-1 trial, in which a mortality
reduction was seen in Veklury-treated patients on low flow oxygen
at baseline, as compared to placebo, in a post-hoc subgroup
analysis (HR: 0.30; 95% CI: 0.14–0.64). Veklury did not demonstrate
a mortality benefit in the overall population or other baseline
oxygen subgroups in either ACTT-1 or SOLIDARITY.
“When the full results of SOLIDARITY were published in May 2022,
it showed that Veklury reduced mortality and progression to
ventilation for those patients who were oxygenated and not
ventilated. These findings are consistent with other studies, such
as ACTT-1,” said Merdad Parsey, MD, PhD, Chief Medical Officer,
Gilead Sciences. “The WHO guideline plays an important part in
informing COVID-19 treatment in many parts of the world. We are
pleased this guideline update reflects the critical role that
Veklury plays in helping to reduce disease progression or death
from COVID-19. Veklury and generic remdesivir have been made
available to more than 11 million patients around the world, and
it’s the only antiviral treatment recommended by the WHO for both
patients at high risk of progression not requiring oxygen and those
requiring supplemental oxygen.”
In the WHO guideline, patients with severe COVID-19 are defined
as those with oxygen saturation less than 90% on room air, signs of
pneumonia and/or signs of severe respiratory distress; it does not
include critically ill patients on mechanical ventilation. Numerous
credible national and international organizations, including the
U.S. National Institutes of Health (NIH) and the European Society
of Clinical Microbiology and Infectious Diseases (ESCMID),
recommend Veklury for the treatment of COVID-19 across a broad
spectrum of disease severity, including both non-severe COVID-19
patients at high risk of hospitalization and patients with severe
COVID-19.
“The WHO’s latest COVID-19 guideline update will help further
expand access for remdesivir to those with more significant disease
who are in need of effective treatment options,” said Dr. Elizabeth
Sapey, BSc, MBBS, PhD, FRCP, Professor of Acute and Respiratory
Medicine at the Institute of Inflammation and Ageing, University of
Birmingham. “With this new recommendation, the WHO guideline now
better reflects the full body of evidence supporting remdesivir’s
role in COVID-19 treatment and aligns more closely with
recommendations in most major guidelines and protocols.”
About Veklury
Veklury (remdesivir) is a nucleotide analog invented by Gilead,
building on more than a decade of the company’s antiviral research.
Remdesivir has an established safety profile and minimal drug
interactions in diverse populations. 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. At this time, more than half of patients hospitalized
with COVID-19 in the United States are treated with Veklury. 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 was approved by the FDA in October 2020, 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. In
January 2022, the FDA approved a sNDA to expand the indication to
non-hospitalized adult and adolescent patients who are at high risk
of progression to severe COVID-19, including hospitalization or
death. This allows for Veklury to be administered in qualified
outpatient settings that can administer daily intravenous (IV)
infusions over three consecutive days. In April 2022, Veklury was
approved by the FDA for the treatment of pediatric patients over 28
days old and weighing at least 3 kg who are hospitalized or not
hospitalized and at high risk of progression to severe COVID-19,
including hospitalization or death. 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.
Veklury directly inhibits viral replication inside of the cell
by targeting the SARS-CoV-2 viral RNA polymerase. Due to Veklury’s
mechanism of action, it has a high barrier to resistance. In vitro
laboratory testing in multiple independent studies show that
Veklury continues to demonstrate durable activity against SARS-CoV2
as it evolves, including the Delta variant and Omicron variants
BA.4 and BA.5. As new SARS-CoV-2 variants of concern emerge around
the world, Gilead continuously evaluates the effectiveness of
Veklury against viral variants.
Veklury is approved or authorized for temporary use in
approximately 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 (at least 28
days old and weighing at least 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 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; the
risk that physicians may not see the benefits of prescribing
Veklury for the treatment of severely ill patients with COVID-19;
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 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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