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
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)
– See more at: http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1898622&highlight=#sthash.IS6nVoqS.dpuf