European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All ...
June 23 2017 - 7:35AM
Business Wire
– Vosevi is Gilead’s Fourth Sofosbuvir-Based
Treatment to Receive CHMP Positive Opinion for the Treatment of
Chronic HCV Infection –
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 8, 2017.
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, 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 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 forward-looking statements.
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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version on businesswire.com: http://www.businesswire.com/news/home/20170623005247/en/
Gilead Sciences, Inc.InvestorsSung Lee, +1 650-524-7792orMedia
(U.S.)Mark Snyder, +1 650-522-6167orMedia (Europe)Arran Attridge,
+44 (208) 587-2477
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