October 28, 2015
Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C
-- If Approved, Combination Would Be First All-Oral, Pan-Genotypic
Single-Tablet Regimen for Chronic HCV Infection --
-- Filing is Company’s Third in Three Years for a New HCV Medicine
FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 28, 2015--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for an investigational, once-daily fixed-dose
combination of the nucleotide analog polymerase inhibitor sofosbuvir
(SOF), approved as Sovaldi® in December 2013, and velpatasvir
(VEL), an investigational pan-genotypic NS5A inhibitor, for the
treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The
NDA is supported by clinical studies exploring the use of 12 weeks of
SOF/VEL for patients with genotype 1-6 HCV infection, including patients
with compensated cirrhosis and 12 weeks of SOF/VEL with ribavirin for
patients with decompensated cirrhosis.
“As the first fixed-dose combination of two pan-genotypic, direct-acting
antivirals, SOF/VEL represents an important step forward in the
treatment of patients with hepatitis C,” said Norbert Bischofberger,
PhD, Executive Vice President of Research and Development and Chief
Scientific Officer at Gilead. “Genotype 1 is the most prevalent form of
HCV in the United States, but worldwide, more than half of people living
with HCV are infected with other genotypes. SOF/VEL complements our
current HCV portfolio of Sovaldi and Harvoni, offering high cure rates
and the potential to simplify treatment and eliminate the need for HCV
The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which
is granted to investigational medicines that may offer major advances in
treatment over existing options. The NDA for SOF/VEL is supported by
data from 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. Those who received
SOF/VEL plus RBV for 12 weeks achieved an SVR12 rate of 94 percent,
while those who received SOF/VEL for 12 weeks and 24 weeks achieved
SVR12 rates of 83 percent and 86 percent, respectively.
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 were headache,
fatigue and nausea. The most common adverse events in ASTRAL-4 were
fatigue, nausea and headache.
Gilead plans to submit a regulatory application for approval of SOF/VEL
in the European Union by the end of the year.
The SOF/VEL fixed-dose combination is an investigational product and its
safety and efficacy have 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. 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 FDA may not approve the SOF/VEL fixed-dose combination, and that
any marketing approvals, if granted, may have significant limitations on
its use. In addition, Gilead may be unable to file for regulatory
approval of SOF/VEL in other geographies in the currently anticipated
timelines. Further, additional clinical studies of SOF/VEL may produce
unfavorable results. 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 June 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.
U.S. full prescribing information for Sovaldi and Harvoni is
available at www.gilead.com.
Sovaldi and Harvoni are registered trademarks of Gilead Sciences,
Inc. or its related companies.
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/20151028006842/en/
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936