January 04, 2016
Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection
-- Final FDA Decision Anticipated by June 28, 2016 --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 4, 2016--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food
and Drug Administration (FDA) has granted priority review to the
company’s New Drug Application (NDA) 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.
Gilead filed the NDA for SOF/VEL on October 28, 2015, and FDA has set a
target action date under the Prescription Drug User Fee Act (PDUFA) of
June 28, 2016.
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. A marketing application for
SOF/VEL is also under review in the European Union, and was validated by
the European Medicines Agency (EMA) in December. 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 worldwide. Gilead has operations in more
than 30 countries worldwide, with headquarters in Foster City,
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. 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
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.
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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Flood, 650-522-5643 (Media)