April 07, 2014
Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection
-- Final FDA Decision Anticipated by October 10, 2014 --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 7, 2014--
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 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. Gilead
filed the NDA for LDV/SOF on February 10, 2014, and the FDA has set a
target action date under the Prescription Drug User Fee Act (PDUFA) of
October 10, 2014.
The FDA has also assigned LDV/SOF a Breakthrough Therapy designation.
The FDA grants Breakthrough Therapy designation and priority review
status to investigational medicines that may offer major advances in
treatment over existing options. The data submitted in the NDA are from
three Phase 3 studies, ION-1, ION-2 and ION-3, and support the use of
LDV/SOF in adults with genotype 1 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.
A marketing application for LDV/SOF is also under review in the European
Union, and was validated by the European Medicines Agency (EMA) on March
27, 2014. The agency has accepted Gilead’s request for accelerated
assessment of LDV/SOF, a designation that is granted to new 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 have
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 the FDA, EMA and other regulatory agencies may not approve LDV/SOF
fixed-dose combination in the currently anticipated timelines or at all,
and that any marketing approvals, if granted, may have significant
limitations on its use. Further, additional 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 Annual Report on Form 10-K for the year ended
December 31, 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)