European CHMP Adopts Positive Opinion for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of...
May 27 2016 - 7:25AM
Business Wire
--Epclusa is Gilead’s Third Sofosbuvir-Based
Treatment to Receive a 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 Epclusa®, an investigational, pan-genotypic,
once-daily tablet containing the nucleotide analogue polymerase
inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an
investigational pan-genotypic NS5A inhibitor, for the treatment of
chronic hepatitis C virus (HCV) infection. The data included in the
application support the use of Epclusa (SOF/VEL) in adults with all
genotypes (GT1-6) of HCV infection.
The CHMP positive opinion was adopted following an accelerated
review 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 Epclusa is supported by data from four Phase 3
studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the
ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with
genotypes 1-6 HCV infection, without cirrhosis or with compensated
cirrhosis (Child-Pugh A) received 12 weeks of Epclusa. The ASTRAL-4
study randomized 267 patients with genotypes 1-6 HCV infection,
with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of
Epclusa with or without ribavirin (RBV) or 24 weeks of Epclusa. The
primary endpoint for each study was sustained virologic response 12
weeks after completing therapy (SVR12).
Of the 1,035 patients treated with Epclusa for 12 weeks in the
ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent)
achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis
receiving Epclusa with RBV for 12 weeks achieved a high SVR12 rate
(94 percent) compared to those who received Epclusa for 12 weeks or
24 weeks without RBV (83 percent and 86 percent, respectively). The
most common adverse events in the four ASTRAL studies were
headache, fatigue and nausea, and were comparable in incidence to
the placebo group included in ASTRAL-1.
Sofosbuvir as a single agent was granted marketing authorization
in the European Union on January 16, 2014, under the trade name
Sovaldi®. The fixed-dose combination of sofosbuvir and ledipasvir
received marketing authorization in the European Union on November
18, 2014, under the trade name Harvoni®.
Gilead has also submitted a regulatory application for SOF/VEL
in the United States. Gilead filed the NDA for SOF/VEL on October
28, 2015, and the Food and Drug Administration (FDA) has set a
target action date under the Prescription Drug User Fee Act (PDUFA)
of June 28, 2016.
Epclusa is an investigational product and its safety and
efficacy has not yet been established.
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 the European Commission or other regulatory
agencies, including the FDA, may not approve SOF/VEL 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 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 10-Q for the quarter ended March 31, 2016, 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 and Harvoni are available from the EMA
website at www.ema.europa.eu
Epclusa, 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
1-650-574-3000.
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version on businesswire.com: http://www.businesswire.com/news/home/20160527005292/en/
Gilead Sciences, Inc.InvestorsSung Lee, +1 650-524-7792orMedia
(Europe)Arran Attridge, +44 208-587-2477orMedia (U.S.)Cara Miller,
+1 650-522-1616
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