|[December 06, 2013]
U.S. Food and Drug Administration Approves Gilead's Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C
FOSTER CITY, Calif. --(Business Wire)--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food
and Drug Administration (FDA) has approved Sovaldi™ (sofosbuvir) 400 mg
tablets, a once-daily oral nucleotide analog polymerase inhibitor for
the treatment of chronic hepatitis C (CHC) infection as a component of a
combination antiviral treatment regimen. Sovaldi's efficacy
has been established in subjects with hepatitis C virus (HCV) genotypes
1, 2, 3 or 4 infection, including those with hepatocellular carcinoma
meeting Milan criteria (awaiting liver transplantation) and those with
HCV/HIV-1 co-infection. Recommended regimens and treatment duration for
Sovaldi combination therapy in HCV mono-infected or HCV/HIV-1
co-infected patients follows:
Sovaldi Product Photo
Genotype 1 or 4
Sovaldi + peg-interferon alfa
Sovaldi + ribavirin
Sovaldi + ribavirin
Sovaldi in combination with ribavirin for 24 weeks can be considered for
CHC patients with genotype 1 infection who are interferon ineligible.
Additionally, Sovaldi should be used in combination with ribavirin for
treatment of CHC patients with hepatocellular carcinoma awaiting liver
transplantation for up to 48 weeks or until liver transplantation to
prevent post-transplant HCV infection. Treatment regimen, duration and
response to Sovaldi are dependent on viral genotype and patient
population, and associated baseline factors. Monotherapy is not
recommended. Full Prescribing Information will be available on www.Gilead.com.
The FDA granted Sovaldi Priority Review and Breakthrough Therapy
designation, which is granted to investigational medicines that may
offer major advances in treatment over existing options.
"I believe that Sovaldi will have a major impact on public health by
significantly increasing the number of Americans who are cured of
hepatitis C," said Ira Jacobson, MD, Chief of the Division of
Gastroenterology and Hepatology, Weill Cornell Medical College, New York
City and a principal investigator in the Sovaldi clinical trials. "In
clinical studies, Sovaldi in combination with other agents achieved very
high cure rates while shortening the duration of treatment to as little
as 12 weeks and reducing or completely eliminating the need for
interferon injections, depending on the viral genotype."
Chronic hepatitis C affects an estimated 4 million people in the United
States, the majority of whom are "baby boomers" - individuals born
between 1945 and 1965. The disease is the nation's leading cause of
liver cancer and liver transplantation, and in recent years has
surpassed HIV/AIDS as a cause of death. The current standard of care for
HCV involves up to 48 weeks of therapy with a pegylated interferon
(peg-IFN)/ribavirin (RBV)-containing regimen, which may not suitable for
certain types of patients.
"It is our hope that Sovaldi will mark the beginning of a new era in
hepatitis C treatment. Gilead is proud to have played a role in bringing
about this important therapeutic advance and we would like to extend our
thanks to the many patients and physicians who partnered with us on
Sovaldi's clinical studies," said John C. Martin, PhD, Chairman and
Chief Executive Officer, Gilead Sciences.
Sovaldi's approval is supported primarily by data from four Phase 3
studies, NEUTRINO, FISSION, POSITRON and FUSION, which evaluated 12 or
16 weeks of treatment with Sovaldi combined with either RBV or RBV plus
peg-IFN. Three of these studies evaluated Sovaldi plus RBV in genotype 2
or 3 patients who were either treatment-naïve (FISSION),
treatment-experienced (FUSION) or peg-IFN intolerant, ineligible or
unwilling (POSITRON). NEUTRINO evaluated Sovaldi in combination with
Peg-IFN/RBV in treatment naïve patients with genotypes 1, 4, 5 or 6. In
these studies, Sovaldi-based therapy was found to be superior to
historical controls (NEUTRINO and FUSION) or to placebo (POSITRON), or
non-inferior to currently available treatment options (FISSION) based on
the proportion of patients who had a sustained virologic response (HCV
undetectable) 12 weeks after completing therapy (SVR12). Patients who
achieve SVR12 are considered cured of HCV. Trial participants taking
Sovaldi-based therapy achieved SVR12 rates of 50-90 percent. For full
study details, see the Clinical Studies section of the full Prescribing
During the FDA's review, data from two additional Phase 3 studies,
VALENCE and PHOTON-1, were added to the NDA as a result of the
Breakthrough Designation status. In the VALENCE study, patients with
genotype 3 HCV infection were treated with Sovaldi and RBV for 24 weeks.
Eighty-four percent of patients in this trial achieved SVR12. The
PHOTON-1 study evaluated Sovaldi and RBV for 12 weeks in patients with
genotype 2 HCV infection co-infected with HIV-1 and for 24 weeks in
patients with genotypes 1 or 3 HCV co-infected with HIV-1. Trial
participants achieved SVR12 rates of 76-92 percent. In all Phase 3
studies of Sovaldi, no viral resistance to the drug was detected among
patients who relapsed following completion of therapy.
To date, nearly 3,000 patients have received at least one dose of
Sovaldi in Phase 2 or 3 studies. Sovaldi combination therapy was well
tolerated in clinical studies. Adverse events were generally mild and
there were few treatment discontinuations due to adverse events. The
most common adverse events occurring in at least 20 percent of patients
receiving Sovaldi in combination with Peg-IFN/RBV were fatigue,
headache, nausea, insomnia and anemia; see below for Important Safety
Information regarding contraindications, warnings and precautions,
adverse reactions and drug interactions.
On November 22, 2013, the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA (News - Alert)) issued a positive opinion
on Gilead's application for marketing authorization for Sovaldi. The
CHMP opinion was adopted following an accelerated review procedure,
which is reserved for medicinal products that are expected to be of
major public health interest. This assessment does not guarantee
marketing authorization by the European Commission. If approved, Sovaldi
could be available in the European Union in the first quarter of 2014.
Applications for marketing approval of Sovaldi are also pending in
Australia, Canada, New Zealand, Switzerland and Turkey.
Dr. Jacobson is a paid consultant to Gilead.
The Wholesaler Acquisition Cost (WAC (News - Alert)) of a 28-tablet bottle of Sovaldi
in the United States is $28,000.
U.S. Patient Assistance Program
Gilead is committed to ensuring that people with hepatitis C can access
Sovaldi and has launched Support Path™ (www.MySupportPath.com)
to provide assistance to patients who are uninsured, underinsured or who
need financial assistance to pay for the medicine. The program consists
of an integrated offering of support services for patients and
Access to dedicated case managers to help patients and their providers
with insurance-related needs, including identifying alternative
coverage options such as federally-insured programs (e.g., Medicaid,
Medicare) and health exchanges.
Education and support, including a 24/7 nursing support service line
and the ability to schedule an onsite visit from a clinical educator.
The Sovaldi Co-pay Coupon Program, which provides co-pay assistance
for eligible patients with private insurance who need assistance
paying for out-of-pocket medication costs. Most patients will pay no
more than $5 per co-pay. Co-pay assistance can also be applied toward
deductibles and co-insurance obligations.
Gilead will provide support to the Patient Access Network (PAN)
Foundation, an independent non-profit organization that provides
assistance for eligible federally-insured and privately-insured
patients who need help covering out-of-pocket medication costs.
The Support Path Patient Assistance Program will provide Sovaldi at no
charge for eligible patients with no other insurance options.
Information about how to apply for any of these forms of assistance can
be found at www.MySupportPath.com
or by calling 1-855-7MyPath (1-855-769-7284) between 9 a.m. - 8 p.m. EST.
Gilead is committed to helping ensure access to Sovaldi in
resource-limited settings. The company is developing a hepatitis C
treatment access program, focusing on those countries with the greatest
HCV burden. Full program details will be announced in the coming months.
Sovaldi is an oral nucleotide analog inhibitor of the HCV NS5B
polymerase enzyme, which plays an essential role in HCV replication.
Sovaldi is a direct-acting agent, meaning that it interferes directly
with the HCV life cycle by suppressing viral replication. Treatment
regimen and duration for Sovaldi are dependent on both viral genotype
and patient population. Treatment response varies based on baseline host
and viral factors. Monotherapy is not recommended for treatment of CHC.
Note to editors: Additional multimedia and information can be found
IMPORTANT SAFETY INFORMATION
Sovaldi combination treatment with ribavirin or with peginterferon alfa
plus ribavirin is contraindicated in women who are pregnant or may
become pregnant and men whose female partners are pregnant because of
the risk for birth defects and fetal death associated with ribavirin.
Contraindications to peginterferon alfa and ribavirin also apply to
Sovaldi combination treatment. Refer to the prescribing information of
peginterferon alfa and ribavirin for a list of their contraindications.
Warnings and Precautions
Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin: Ribavirin
therapy should not be started unless a report of a negative pregnancy
test has been obtained immediately prior to initiation of therapy.
Female patients of childbearing potential and their male partners must
use two forms of non-hormonal contraception during treatment and for
at least 6 months after treatment has concluded. Routine monthly
pregnancy tests must be performed during this time. Refer to the
prescribing information for ribavirin.
Use with Potent P-gp Inducers: Rifampin and St. John's wort
should not be used with Sovaldi as they may significantly decrease
sofosbuvir plasma concentration, reducing its therapeutic effect.
Most common (=20%, all grades) adverse reactions for:
Sovaldi + peginterferon alfa + ribavirin combination therapy were
fatigue, headache, nausea, insomnia, and anemia
Sovaldi + ribavirin combination therapy were fatigue, and headache
In addition to rifampin and St. John's wort, coadministration of Sovaldi
is not recommended with carbamazepine, oxcarbazepine, phenobarbital,
phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such
coadministration is expected to decrease the concentration of
sofosbuvir, reducing its therapeutic effect.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company's mission is to advance the care of patients suffering
from life-threatening diseases worldwide. Headquartered in Foster City,
California, Gilead has operations in North and South America, Europe and
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 physicians and patients may not see advantages of Sovaldi over
other therapies and may therefore be reluctant to prescribe the product,
and the risk that public payers may be reluctant to approve or provide
reimbursement for the product. In addition, pending marketing
applications for Sovaldi in the European Union and other territories may
not be approved in the currently anticipated timelines or at all, and
marketing approval, if granted, may have significant limitations on its
use. 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
September 30, 2013, 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 Sovaldi is available at www.Gilead.com
Sovaldi and Support Path are trademarks or registered
trademarks of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company's
website at www.gilead.com,
follow Gilead on Twitter (News - Alert) (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
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