February 10, 2014
Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C
-- If Approved, Fixed-Dose Combination Would be First Oral
Treatment Regimen for Patients with Genotype 1 HCV Infection,
Eliminating Need for Both Interferon and Ribavirin --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 10, 2014--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company
has submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for a once-daily fixed-dose combination of the NS5A
inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase
inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis
C genotype 1 infection in adults. The data submitted in the NDA support
the use of LDV/SOF in patients with genotype 1 hepatitis C virus (HCV)
infection, with a treatment duration of eight or 12 weeks depending on
prior treatment history and whether they have cirrhosis. Approximately
75 percent of people infected with HCV in the United States have the
genotype 1 strain of the virus.
“Today’s filing brings us one step closer to our goal of offering all
patients with hepatitis C a simple, safe and highly effective all-oral
treatment regimen,” said Norbert Bischofberger, PhD, Executive Vice
President of Research and Development and Chief Scientific Officer.
“Based on the data from the Phase 3 ION studies, the LDV/SOF combination
may have the potential to cure HCV in genotype 1 patients in as little
as eight weeks and without the need for interferon injections or
The FDA has assigned LDV/SOF a Breakthrough Therapy designation, which
is granted to investigational medicines that may offer major advances in
treatment over existing options. The NDA for LDV/SOF is supported by
three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000
genotype 1 HCV patients were randomized to receive the fixed-dose
combination, with or without RBV, for treatment durations of eight, 12
or 24 weeks. Trial participants included patients who were
treatment-naïve or who had failed previous treatment, including protease
inhibitor-based regimens, and also included patients with compensated
Gilead plans to file for regulatory approval of LDV/SOF in other
geographies, including the European Union, in the first quarter of 2014.
Gilead has submitted an application to the European Medicines Agency
(EMA) for accelerated assessment of LDV/SOF, a designation that is
granted to new therapies and medicines of major public health interest.
If accepted, accelerated assessment could shorten the EMA’s review time
of LDV/SOF by two months, although it does not guarantee a positive
opinion from the Committee for Medicinal Products for Human Use or
approval by the European Commission.
LDV/SOF is an investigational product and its safety and efficacy has
not yet been established.
SOF as a single agent was approved by the FDA under the tradename Sovaldi®
on December 6, 2013 and by the European Commission on January 17, 2014.
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 FDA may not approve the LDV/SOF 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 LDV/SOF in other geographies in the currently anticipated
timelines. Further, additional clinical studies of LDV/SOF, including
results from the 24-week arms of ION-1, may produce unfavorable results.
As a result, Gilead may not be able to successfully commercialize
LDV/SOF, and may make a strategic decision to discontinue its
development if, for example, the market for the product fails to
materialize as expected. 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 is a registered trademark of Gilead Sciences, Inc.
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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Miller, 650-522-1616 (Media)