European CHMP Adopts Positive Opinion for Gilead’s Vemlidy® (Tenofovir Alafenamide, TAF) for the Treatment of Chronic Hepa...
November 11 2016 - 7:25AM
Business Wire
-- Vemlidy Demonstrated Similar Efficacy
with Improvements in Renal and Bone Laboratory Safety Parameters
Compared to Viread in Phase 3 Studies --
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 Vemlidy® (tenofovir alafenamide, TAF) 25 mg,
an investigational, once-daily tablet for the treatment of chronic
hepatitis B virus (HBV) infection in adults and adolescents
(≥ 12 years and ≥ 35 kg body weight). The data included in the
application support the use of TAF in treatment-naïve and
treatment-experienced adults and adolescents with HBeAg-negative
and HBeAg-positive HBV infection.
TAF is a novel, targeted prodrug of tenofovir that has
demonstrated antiviral efficacy similar to and at one-tenth the
dose of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 245
mg. Data show that because TAF has greater plasma stability and
more efficiently delivers tenofovir to hepatocytes compared to TDF,
it can be given at a lower dose, resulting in less tenofovir in the
bloodstream. As a result, TAF improved certain renal and bone
laboratory safety parameters compared to TDF in clinical
trials.
The CHMP’s 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 TAF includes data from two international Phase 3
studies (Studies 108 and 110) in 1,298 treatment-naïve and
treatment-experienced patients with HBV infection. Study 108
randomized 425 HBeAg-negative patients to receive either TAF or
TDF, and Study 110 randomized 873 HBeAg-positive patients to
receive either TAF or TDF. The full data from Studies 108 and 110
were presented at the International Liver Congress™ (ILC) earlier
this year.
TAF as a single-agent for HBV is an investigational product and
its 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. 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 may not approve TAF for the treatment of chronic hepatitis
B 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 TAF for chronic hepatitis B.
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 September 30, 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.
Viread
Please refer to the Viread individual Summary of Product
Characteristics for full prescribing information.
Any suspected adverse reactions to Viread should be reported
to Gilead via email to safety_FC@gilead.com or by
telephone +44 (0) 1223 897500.
The European SmPC for Viread is available from
the EMA website at www.ema.europa.eu
Vemlidy and Viread are registered trademarks of
Gilead Sciences, Inc.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161111005286/en/
Gilead Sciences, Inc.Sung Lee, +1-650-524-7792InvestorsorKelsey
Grossman, +1-650-378-2103Media (U.S.)
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Apr 2023 to Apr 2024