-- Approval Based on Phase 3 Data Showing
Veklury Significantly Reduced Risk of Hospitalization By 87%
Compared with Placebo --
-- NIH Guidelines Recommend Veklury for the
Treatment of Non-Hospitalized Patients at High Risk --
-- FDA Expands Pediatric Emergency Use
Authorization (EUA) to Include Treatment of Non-Hospitalized
Pediatric Patients at High Risk --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
U.S. Food and Drug Administration (FDA) has granted expedited
approval of a supplemental new drug application (sNDA) for Veklury®
(remdesivir) for the treatment of non-hospitalized adult and
adolescent patients who are at high risk of progression to severe
COVID-19, including hospitalization or death. This approval expands
the role of Veklury, which is the antiviral standard of care for
the treatment of patients hospitalized with COVID-19. The expanded
indication allows for Veklury to be administered in qualified
outpatient settings that can administer daily intravenous (IV)
infusions over three consecutive days. The FDA has also expanded
the pediatric Emergency Use Authorization (EUA) of Veklury to
include non-hospitalized pediatric patients younger than 12 years
of age who are at high risk of disease progression.
These actions by the FDA come amidst a surge in COVID-19 cases
and the reduced susceptibility to several anti-SARS-CoV-2
monoclonal antibodies (mAbs) due to the Omicron variant. In
contrast, Veklury targets the highly conserved viral RNA
polymerase, thereby retaining activity against existing SARS-CoV-2
variants of concern. In vitro laboratory testing shows that Veklury
retains activity against the Omicron variant. To date, no major
genetic changes have been identified in any of the known variants
of concern that would significantly alter the viral RNA polymerase
targeted by Veklury.
The FDA sNDA approval, pediatric EUA expansion and recently
updated National Institutes of Health (NIH) Treatment Guidelines
for COVID-19 that additionally recommend Veklury for treatment in
non-hospitalized settings, are based on results from the PINETREE
Phase 3 randomized, double-blind, placebo-controlled trial. The
trial evaluated the efficacy and safety of a three-day course of
Veklury for intravenous (IV) use for the treatment of COVID-19 in
non-hospitalized patients at high risk for disease progression. An
analysis of 562 participants randomly assigned in a 1:1 ratio to
receive Veklury or placebo, demonstrated that treatment with
Veklury resulted in a statistically significant 87% reduction in
risk for the composite primary endpoint of COVID-19 related
hospitalization or all-cause death by Day 28 (0.7% [2/279])
compared with placebo (5.3% [15/283]) p=0.008. In the study, no
deaths were observed in either arm by Day 28. The safety profile
was similar between Veklury and placebo across the variety of
outpatient settings in this trial, with the most common treatment
emergent adverse events (≥5%) in patients taking Veklury being
nausea and headache.
“Remdesivir has now helped to treat more than 10 million people
around the world with COVID-19 and continues to play a key role in
helping to reduce the burden of the pandemic. Based on the most
recent data, we now understand that remdesivir is also effective in
the early stages of COVID-19 infection, in addition to helping
patients who are hospitalized with the disease,” said Daniel O’Day,
Chairman and Chief Executive Officer, Gilead Sciences. “While we
continue to advance remdesivir to benefit more patients in multiple
settings, we are also advancing our investigational oral compounds.
These are based on the same antiviral mechanism of action as
remdesivir and a Phase 1 trial for our oral COVID-19 antiviral,
GS-5245 is now underway.”
In the United States, Veklury is indicated for the treatment of
COVID-19 in adults and pediatric patients (12 years of age and
older and weighing at least 40 kg) who are either hospitalized or
not hospitalized and are at high risk for progression to severe
COVID-19, including hospitalization or death. Veklury is
additionally authorized for these uses under the EUA for pediatric
patients weighing 3.5 kg to less than 40 kg or pediatric patients
less than 12 years of age weighing at least 3.5 kg. 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.
Under the expanded indication for Veklury, non-hospitalized
adult and pediatric patients (12 years of age and older and
weighing at least 40 kg) with confirmed SARS-CoV-2 infection who
are at high risk for COVID-19 disease progression can be treated
with a recommended treatment duration of three days to help prevent
hospitalization. For hospitalized patients not on mechanical
ventilation and/or ECMO, a 5-day course of treatment is
recommended, with the option to extend to a total of 10-days as
needed. Critically ill patients who require mechanical ventilation
and/or ECMO should receive a 10-day course of treatment.
Updates to Veklury Distribution in the
U.S.
Gilead has been meeting U.S. and global demand for Veklury for
the treatment of hospitalized patients, without disruption since
October 2020 after FDA approval. Gilead will now work with
distributors to make Veklury available in qualified outpatient
facilities, including providing product information to non-hospital
settings, to help meet the unprecedented demand for early treatment
options brought on by the current COVID-19 surge. In accordance
with the recommendations provided by the National Institutes of
Health (NIH) COVID-19 Treatment Guidelines, which prioritize
treatment for those patients who are at the highest risk of
progressing to severe COVID-19, our goal is to continue to ensure
uninterrupted supply for inpatient hospital use while expanding to
outpatient facilities as well. Gilead will enable outpatient
ordering in a tiered approach that will start with hospital
outpatient departments due to their experience and familiarity with
the administration of Veklury; then outpatient ordering will be
available to other qualified outpatient facilities.
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 the antiviral standard of care for the treatment of
hospitalized patients with COVID-19. 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 hospitalized patients to
recover faster, freeing up limited hospital resources and saving
healthcare systems money.
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 10 million
patients around the world, including 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 (12 years of
age and older and weighing at least 40 kg) with positive results of
direct 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.
Veklury should only be administered in settings in which health
care providers have immediate access to medications to treat a
severe infusion or hypersensitivity reaction, such as anaphylaxis,
and the ability to activate the emergency medical system (EMS), as
necessary. Veklury must be administered by intravenous infusion.
Veklury is contraindicated in patients who are allergic to Veklury
or any of its components. For more information, please see the U.S.
full Prescribing Information available at www.gilead.com.
U.S. Important Information for Veklury
Emergency Use for Pediatric Patients
The U.S. Food and Drug Administration (FDA) has issued an
Emergency Use Authorization (EUA) to permit the emergency use of
Veklury for the treatment of COVID-19 in pediatric patients
weighing 3.5 kg to less than 40 kg or
pediatric patients less than 12 years of age weighing at least 3.5
kg with positive results of direct 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.
Veklury has been authorized by FDA for these emergency uses.
Veklury is not FDA-approved for these uses. Veklury is authorized
for these uses only for the duration of the declaration that
circumstances exist justifying the authorization of the emergency
use of Veklury, unless the authorization is terminated or revoked
sooner.
The only authorized dosage form of Veklury for use in pediatric
patients under the EUA is Veklury 100 mg for injection, supplied as
a lyophilized powder. For information about the authorized use of
Veklury, including dosage and administration instructions for
pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age
weighing at least 3.5 kg, please see the Fact Sheet for Healthcare
Providers, available here.
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 ≥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. Veklury should be initiated as soon as
possible after diagnosis of symptomatic COVID-19.
- Treatment duration:
- For hospitalized patients requiring invasive mechanical
ventilation and/or ECMO, the recommended total treatment duration
is 10 days.
- 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.
- 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: 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.
Adverse Event Reporting
For use under the EUA, healthcare providers and/or their
designee are responsible for mandatory FDA MedWatch reporting of
all serious adverse events and medication errors potentially
related to Veklury within 7 calendar days from the healthcare
provider’s awareness of the event. Healthcare providers are
additionally encouraged to report adverse events occurring under
the approved use of Veklury. 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 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, including for the use of Veklury in
non-hospitalized patients in the United States; the possibility of
unfavorable results from ongoing or additional clinical trials
involving Veklury; Gilead’s ability to initiate, progress or
complete clinical trials within currently anticipated timelines or
at all, including those involving Veklury, GS-5245 and other
investigational oral compounds; Gilead’s ability to receive
regulatory approvals in a timely manner or at all, including
additional regulatory approvals of Veklury, and the risk that any
such approvals may be subject to significant limitations on use;
the risk that physicians may not see the benefits of prescribing
Veklury; 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
September 30, 2021, 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
involves 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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Jacquie Ross, Investors (408) 656-8793
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