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. -- April 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
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 Asia Pacific.
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.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)
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