Japan’s Ministry of Health, Labour & Welfare Approves Gilead’s Sovaldi® (sofosbuvir) for the Treatment of Genotype 2 Chr...
March 26 2015 - 2:00AM
Business Wire
-- Sovaldi Part of First All-Oral Treatment
Regimen for Genotype 2 Patients in Japan --
-- 96 Percent Cure Rates and Shortened,
12-Week Course of Therapy --
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the
Japanese Ministry of Health, Labour and Welfare (MHLW) has approved
Sovaldi® (sofosbuvir), a once-daily nucleotide analog polymerase
inhibitor, for the suppression of viremia in patients with genotype
2 chronic hepatitis C virus (HCV) infection with or without
compensated cirrhosis. Sovaldi is indicated for use in combination
with ribavirin (RBV) for 12 weeks. Sovaldi (in combination with
RBV) is the first all-oral, interferon-free treatment regimen for
genotype 2 HCV infection. Sovaldi is also the first product to be
marketed by Gilead in Japan.
“Today’s approval represents an important step forward in the
management of hepatitis C in Japan, enabling genotype 2
infected patients the opportunity of a cure in 12 weeks with an
all-oral regimen that eliminates the need for interferon,” said
Masao Omata, MD, Yamanashi Prefectural Hospital Organization.
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 chronically infected with HCV, 20-30
percent have the genotype 2 strain of the virus. Currently approved
therapies in Japan for genotype 2 HCV infection involve
24-48 weeks of injections with pegylated interferon, which may not
be suitable for many patients.
Sovaldi’s approval is supported by data from a Phase 3 clinical
trial conducted in Japan (Study GS-US-334-0118) among
treatment-naïve and treatment-experienced genotype 2 patients.
Approval was based on 96 percent (n=135/140) of genotype 2
HCV-infected patients who received 12 weeks of an all-oral regimen
of Sovaldi plus RBV 600–1,000 mg/day achieving a sustained
virologic response 12 weeks after completing therapy (SVR12).
Patients who achieve SVR12 are considered cured of HCV infection.
The approval is also supported by SVR12 results from four
international Phase 3 studies (FISSION, FUSION, POSITRON and
VALENCE), which included genotype 2 HCV patients.
“There is a need in Japan for new HCV treatment
options that are more effective and better tolerated and we have
been pleased to partner with the medical community here in Japan to
demonstrate the efficacy and safety of Sovaldi,” said Norbert
Bischofberger, PhD, Gilead’s Executive Vice President, Research and
Development and Chief Scientific Officer. “We look forward to
making Sovaldi available in Japan as quickly as possible, while
simultaneously continuing to work with the agency on its review of
our second application for an all-oral sofosbuvir-based regimen for
the treatment of genotype 1 HCV infection.”
Gilead filed a New Drug Application (NDA) in Japan for a
single-tablet regimen of sofosbuvir and the NS5A inhibitor
ledipasvir for the treatment of genotype 1 HCV infected patients on
September 24, 2014. The ledipasvir/sofosbuvir single tablet regimen
is an investigational product in Japan and its safety and efficacy
have not yet been established.
IMPORTANT SAFETY
INFORMATION
Use with potent P gp inducers: Drugs that are potent P-gp
inducers in the intestine are expected to decrease sofosbuvir
plasma concentration. Sovaldi is contraindicated in patients
receiving the following substances: carbamazepine, phenytoin,
rifampicin or St. John’s wort. Also, Sovaldi should be administered
with care when coadministered with the following drugs: rifabutin,
and phenobarbital.
Contraindications: Sovaldi is contraindicated in patients with
severe renal function impairment (eGFR<30 mL/min/1.73m2) or
patients with renal insufficiency requiring dialysis.
Anemia occurred in patients receiving Sovaldi in combination
with ribavirin. Patients should be carefully observed and
hemoglobin should be periodically monitored and appropriate
measures should be taken including ribavirin dose adjusted
according to the ribavirin package insert. If ribavirin is
permanently discontinued, Sovaldi should also be discontinued.
Adverse reactions: In the Japanese Phase 3 clinical study, 61 of
140 (43.6 percent) patients experienced adverse reactions,
including abnormal laboratory test values. The major adverse
reactions were 21 anemia/hemoglobin decreased (15.0 percent), 7
headache (5.0 percent), 6 malaise (4.3 percent), 6 nausea (4.3
percent), and 6 pruritus (4.3 percent).
About Gilead
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. Gilead has
operations in more than 30 countries worldwide, with headquarters
in Foster City, California.
Forward-Looking
Statement
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 physicians and patients may not see
advantages of Sovaldi over other therapies and may therefore be
reluctant to prescribe the product, and the risk that payers may be
reluctant to approve or provide reimbursement for the product.
Further, the ledipasvir/sofosbuvir single tablet regimen may not be
approved in Japan in the currently anticipated timelines or at all,
and approval, if granted, may have significant limitations on its
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 Annual Report on Form 10-K for the
year ended December 31, 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 statements.
U.S. full Prescribing Information for Sovaldi
and Harvoni is available at www.gilead.com.Sovaldi and Harvoni are
registered trademarks of Gilead Sciences, Inc., or its related
companies.
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.Investors:Patrick O’Brien, +1
650-522-1936Media:Cara Miller, +1 650-522-1616Seiko Noma,
+81-3-6837-0790 (Japan)
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