December 04, 2015
European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C
-- If Approved, SOF/VEL Would be the First All-Oral, Pan-Genotypic
Single Tablet Regimen for Chronic HCV in Europe --
-- SOF/VEL Granted an Accelerated Assessment by the European
Medicines Agency --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 4, 2015--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its Marketing
Authorization Application (MAA) for an investigational, once-daily
fixed-dose combination of the nucleotide analog polymerase inhibitor
sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational
pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C
virus (HCV) infection, has been fully validated and is now under
assessment by the European Medicines Agency (EMA). The data included in
the application, which was submitted on November 17, 2015, support the
use of SOF/VEL among patients with genotype 1-6 HCV infection, including
patients with compensated and decompensated cirrhosis.
“Despite advances in the treatment of HCV, there is a need for simple,
highly effective pan-genotypic therapies, particularly for patients with
genotype 3 HCV infection, who traditionally have been more difficult to
cure,” said Norbert Bischofberger, PhD, Executive Vice President of
Research and Development and Chief Scientific Officer at Gilead. “If
approved, SOF/VEL will represent a significant step forward in the
potential to control and eliminate hepatitis C, as the first and only
fixed-dose regimen offering high SVR rates with just 12 weeks of
treatment for patients with all HCV genotypes.”
The MAA for SOF/VEL is supported by four Phase 3 ASTRAL trials, which
evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of
the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1,
ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved the primary
efficacy endpoint of SVR12. The ASTRAL-4 study randomized 267 patients
with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of
SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL.
Ninety-four percent of patients who received SOF/VEL plus RBV for 12
weeks achieved an SVR12, while 83 percent and 86 percent of patients who
received SOF/VEL for 12 weeks and 24 weeks, respectively, achieved
SVR12. These data were presented at the American Association for the
Study of Liver Diseases (AASLD) annual meeting in November 2015, and
were also published in The New England Journal of Medicine.
Patients treated with SOF/VEL for 12 weeks in ASTRAL-1, ASTRAL-2 and
ASTRAL-3 had similar adverse events compared with placebo-treated
patients in ASTRAL-1. The most common adverse events in the four ASTRAL
studies were headache, fatigue and nausea.
SOF/VEL is the third investigational medicinal product from Gilead for
HCV infection to receive Accelerated Assessment by the EMA. This,
however, does not assure a positive opinion from the EMA’s Committee for
Medicinal Products for Human Use (CHMP) or final approval by the
European Commission. Review of the MAA will be conducted under the
centralized licensing procedure, which, if authorized, provides
marketing authorization in all 28 member states of the European Union,
Norway and Iceland. If approved, SOF/VEL could be available for
marketing in the European Union in 2016. Gilead has also submitted a
regulatory application for SOF/VEL in the United States.
SOF/VEL is an investigational product and its safety and efficacy has
not yet 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. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City, California.
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 may not
approve SOF/VEL, 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. 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, 2015, 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
or call Gilead Public Affairs at +44 (208) 587-2477.
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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, +1
Arran Attridge, +44 (208)
Cara Miller, +1 650-522-1616