June 23, 2017
European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Chronic Hepatitis C Genotypes
– Vosevi is Gilead’s Fourth Sofosbuvir-Based Treatment to Receive
CHMP Positive Opinion for the Treatment of Chronic HCV Infection –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 23, 2017--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee
for Medicinal Products for Human Use (CHMP), the scientific committee of
the European Medicines Agency (EMA), has adopted a positive opinion on
the company’s Marketing Authorization Application (MAA) for Vosevi®,
an investigational, once-daily, single tablet regimen of sofosbuvir 400
mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the
treatment of chronic hepatitis C virus (HCV)-infected patients. The data
included in the application support the use of SOF/VEL/VOX in patients
with and without compensated cirrhosis, with all genotypes (GT1-6) of
HCV infection regardless of prior therapy, including 8 weeks of
treatment for HCV direct-acting antiviral (DAA)-naïve patients without
cirrhosis, as well as 12 weeks of treatment for patients who have
previously failed therapy with a DAA-containing regimen.
The CHMP positive opinion was adopted following an accelerated
assessment procedure, reserved for medicinal products expected to be of
major public health interest. The recommendation will now be reviewed by
the European Commission, which has the authority to approve medicines
for use in the 28 countries of the European Union, Norway and Iceland.
The MAA for SOF/VEL/VOX is supported by data from four Phase 3 studies.
Two studies (POLARIS-1 and POLARIS-4), evaluated 12 weeks of the single
tablet regimen in patients with genotypes 1-6 HCV infection previously
treated unsuccessfully with DAA-containing regimens, including NS5A
inhibitors. Two other studies (POLARIS-2 and POLARIS-3) evaluated 8
weeks of SOF/VEL/VOX in DAA-naïve patients with genotypes 1-6
HCV infection. Across POLARIS-1 and POLARIS-4, 97 percent of patients
treated with SOF/VEL/VOX (n=431/445) achieved the primary efficacy
endpoint of SVR12. In POLARIS-2, 95 percent of patients with genotypes
1-6 HCV infection with and without cirrhosis treated with SOF/VEL/VOX
(n=477/501) achieved the primary efficacy endpoint of SVR12. In
POLARIS-3, 96 percent of patients with genotype 3 infection and
cirrhosis treated with SOF/VEL/VOX (n=106/110) achieved the primary
efficacy endpoint of SVR12. The most common adverse events among
patients who received SOF/VEL/VOX in the POLARIS studies were headache,
fatigue, diarrhea and nausea.
Sofosbuvir as a single agent was granted marketing authorization in the
European Union on January 16, 2014, under the trade name Sovaldi®,
for use in combination with other agents. The single tablet regimen of
sofosbuvir (400 mg) and ledipasvir (90 mg) received marketing
authorization in the European Union on November 18, 2014, under the
trade name Harvoni®. The single tablet regimen of sofosbuvir
(400 mg) and velpatasvir (100 mg) received marketing authorization in
the European Union on July 8, 2016, under the trade name Epclusa®.
Gilead has also submitted a regulatory application for SOF/VEL/VOX in
the United States. Gilead filed the New Drug Application for SOF/VEL/VOX
on December 8, 2016, and the Food and Drug Administration (FDA) has set
a target action date under the Prescription Drug User Fee Act of August
SOF/VEL/VOX is an investigational product and its safety and efficacy
has not been established and is not approved anywhere globally.
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. Gilead has operations in more
than 40 countries worldwide, with headquarters in Foster City,
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 European Commission or other regulatory agencies, including the
FDA, may not approve SOF/VEL/VOX for the treatment of chronic hepatitis
C and that any marketing approvals, if granted, may have significant
limitations on its use. As a result, Gilead may not be able to
successfully commercialize SOF/VEL/VOX for chronic hepatitis C. 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 10Q for the quarter ended March 31, 2017, 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
Full European Summary of Product Characteristics for Sovaldi, Harvoni
and Epclusa are available from the EMA website at www.ema.europa.eu.
Vosevi, Sovaldi, Harvoni and Epclusa 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
or call Gilead Public Affairs at 1-650-574-3000.
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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Sung Lee, +1 650-524-7792
Mark Snyder, +1 650-522-6167
Attridge, +44 (208) 587-2477