European Medicines Agency Validates Gilead’s Marketing Authorization Application for Investigational Chronic Hepatitis C Th...
January 20 2017 - 5:48AM
Business Wire
– SOF/VEL/VOX Granted an Accelerated
Assessment by the European Medicines Agency –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
company’s Marketing Authorization Application (MAA) for the
investigational, once-daily, single tablet regimen of sofosbuvir
400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX)
for the treatment of chronic hepatitis C virus (HCV)-infected
patients has been fully validated and is now under assessment by
the European Medicines Agency (EMA).
“Direct-acting antiviral treatments have transformed our ability
to treat hepatitis C; however, for some patients who have failed to
achieve a cure with these regimens, effective and well-tolerated
therapies are still needed,” said Norbert Bischofberger, Ph.D.,
Executive Vice President of Research and Development and Chief
Scientific Officer at Gilead. “The submission of this application
reflects our continued commitment to provide treatment options for
this life-threatening disease to as many patients as possible,
including those who have failed previous direct-acting antiviral
therapy, in Europe and around the world.”
The MAA for SOF/VEL/VOX is supported by data from two Phase 3
studies (POLARIS-1 and POLARIS-4), which evaluated 12 weeks of the
fixed-dose combination in direct-acting antiviral (DAA)-experienced
patients with hepatitis C genotypes 1-6, including those who failed
prior treatment with an NS5A inhibitor-containing regimen. Across
the two studies, 97 percent of patients treated with SOF/VEL/VOX
(n=430/445) achieved the primary efficacy endpoint of SVR12. The
MAA also includes data from two additional phase 3 studies
(POLARIS-2 and POLARIS-3), which evaluated 8 weeks of SOF/VEL/VOX
in 611 DAA-naïve patients with genotypes 1-6. In POLARIS-3, 96
percent of patients with genotype 3 infection and cirrhosis treated
with SOF/VEL/VOX (n=106/110) achieved the primary efficacy endpoint
of SVR12. The most common adverse events among patients who
received SOF/VEL/VOX were headache, fatigue, diarrhea and
nausea.
SOF/VEL/VOX for the treatment of HCV will be reviewed by the EMA
under the centralized licensing procedure for all 28 member states
of the European Union, Norway and Iceland. The review will follow
an accelerated procedure reserved for medicinal products expected
to be of major public health interest. Gilead also submitted a New
Drug Application to the U.S. Food and Drug Administration (FDA) for
SOF/VEL/VOX on December 8, 2016.
SOF/VEL/VOX is an investigational product and its safety and
efficacy has not been established.
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. Gilead
has operations in more than 30 countries worldwide, with
headquarters in Foster City, California.
Forward-Looking
Statement
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 the European Commission or other regulatory
agencies, including the FDA, may not approve SOF/VEL/VOX for the
treatment of chronic hepatitis C and that any marketing approvals,
if granted, may have significant limitations on its use. As a
result, Gilead may not be able to successfully commercialize
SOF/VEL/VOX for chronic hepatitis C. 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 10Q for the quarter ended September 30, 2016, 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.
For more information on Gilead Sciences,
please visit the company’s website at www.gilead.com, follow
Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
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