– SOF/VEL/VOX Granted an Accelerated Assessment by the European
Medicines Agency –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 20, 2017--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170120005204/en/
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.InvestorsSung Lee, 650-524-7792MediaMark
Snyder, 650-522-6167
