September 24, 2014
Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Fixed-Dose Combination of Ledipasvir/Sofosbuvir for Chronic Hepatitis C Genotype 1 Infection
-- 12-Week Course of Ledipasvir/Sofosbuvir Achieved 100 Percent
Sustained Virologic Response (SVR12) in Japanese Phase 3 Study --
-- Ledipasvir/Sofosbuvir Simplifies Hepatitis C Treatment to a
Single, Once-Daily Tablet --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 24, 2014--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has
submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and
Medical Devices Agency (PMDA) for approval of an investigational
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 genotype 1 hepatitis C virus (HCV)
infection in adults. The data submitted in the NDA, which include a
Japanese Phase 3 study showing 100 percent SVR12 rates, support the use
of LDV/SOF for 12 weeks in treatment-naïve and treatment-experienced
patients with chronic genotype 1 HCV infection, including those with
cirrhosis. Patients who achieve SVR12 are cured of HCV infection. If
approved, LDV/SOF would simplify HCV treatment for genotype 1 patients
in Japan to one daily tablet, eliminating the need for interferon and
Primarily due to HCV, Japan has one of the highest rates of liver cancer
of any industrialized country. Of the more than one million people in
Japan chronically infected with HCV, 70-80 percent are infected with the
genotype 1 strain of the virus.
The NDA is based on data from a Phase 3 clinical trial conducted in
Japan (GS-US-337-0113) among 341 treatment-naïve and
treatment-experienced genotype 1 patients. In the study, 100 percent
(n=83/83) of treatment-naïve and 100 percent (n=88/88) of
treatment-experienced patients receiving 12 weeks of LDV/SOF without RBV
achieved SVR12. Adverse events observed with LDV/SOF without RBV were
generally mild and included nasopharyngitis (28 percent), headache (6
percent) and malaise (5 percent).
The NDA is also supported by SVR12 results from three Phase 3 studies
(ION-1, ION-2 and ION-3) evaluating eight, 12 or 24 weeks of LDV/SOF
among genotype 1 HCV patients. Trial participants included patients from
the United States, Europe and Puerto Rico who were treatment-naïve or
who had failed previous treatment, including protease inhibitor-based
regimens, and also included patients with compensated cirrhosis. Trial
participants in the ribavirin-free arms (n=863) achieved SVR12 rates of
94 to 99 percent.
LDV/SOF is currently under regulatory review in the United States and
On June 27, 2014 Gilead submitted an NDA to Japan’s PMDA for SOF as a
single agent in combination with RBV for the treatment of genotype 2 HCV
infection. SOF as a single agent has been approved by regulatory
authorities in the United States, European Union, Australia and Canada
under the tradename Sovaldi®.
LDV/SOF and SOF are investigational products in Japan and their safety
and efficacy have not yet 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
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
possibility of unfavorable results from additional clinical trials
involving SOF or the LDV/SOF fixed-dose combination. Further, the PMDA
and regulatory authorities in the United States and the European Union
may not approve the LDV/SOF fixed-dose combination and the PMDA may not
approve SOF as a standalone agent in Japan, and any marketing approvals,
if granted, may have significant limitations on their use. 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 June 30, 2014, 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
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, +1
Michele Rest, +1 650-577-6935
Seiko Noma, +81-3-6837-0790