– Final FDA Decision on Sofosbuvir Anticipated by December 8, 2013
–
FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 25, 2013--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Antiviral
Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA)
has voted unanimously (15-0) that the available data support approval of
the once-daily nucleotide analogue sofosbuvir in combination with
ribavirin for the treatment of chronic hepatitis C in adult patients
with genotype 2 and 3 infection. Committee members also voted
unanimously (15-0) that the available data support approval of
sofosbuvir in combination with pegylated interferon and ribavirin for
the treatment of chronic hepatitis C in treatment-naïve adult patients
with genotype 1 and 4 infection.
The recommendations of the Advisory Committee are not binding, but will
be considered by FDA as the agency completes its review of Gilead’s New
Drug Application (NDA) for sofosbuvir. Gilead submitted the NDA on April
8, 2013 and was granted a priority review. The FDA also granted
sofosbuvir a Breakthrough Therapy designation. The FDA grants
Breakthrough Therapy designation and priority review status to drug
candidates that may offer major advances in treatment over existing
options. A target review date of December 8, 2013 has been set under the
Prescription Drug User Fee Act (PDUFA). Applications for marketing
approval of sofosbuvir are also pending in the European Union,
Australia, Canada, New Zealand, Switzerland and Turkey.
The sofosbuvir NDA is supported primarily by data from four Phase 3
studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks
of sofosbuvir-based therapy was found to be superior or non-inferior to
currently available treatment options or historical controls, based on
the proportion of patients who had a sustained virologic response (HCV
undetectable) 12 weeks after completing therapy (SVR12). During the
review, data from an additional Phase 3 study, VALENCE, were filed to
the NDA. In this study, patients with genotype 3 HCV infection were
treated with sofosbuvir and ribavirin for 24 weeks. Patients who achieve
SVR12 are considered cured of HCV.
About Sofosbuvir
Sofosbuvir is a nucleotide analogue inhibitor of the HCV NS5B polymerase
enzyme, which plays an essential role in HCV replication. Sofosbuvir is
a direct-acting agent, meaning that it interferes directly with the HCV
life cycle by suppressing viral replication. Sofosbuvir 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 worldwide. Headquartered in Foster City,
California, Gilead has operations in North and South America, Europe and
Asia Pacific.
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 FDA, EMA and other regulatory agencies may not approve sofosbuvir
in the currently anticipated timelines or at all, and that any marketing
approvals, if granted, may have significant limitations on their use. In
addition, future studies of sofosbuvir, including in combination with
other products, may not produce favorable results. Further, even if
approved, Gilead may not be able to successfully commercialize
sofosbuvir, 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 Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 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.
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)Cara
Miller, 650-522-1616 (Media)
