-- Vemlidy® is the First
New Treatment for Chronic Hepatitis B Infection to be Approved in the
European Union in Nearly a Decade --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 11, 2017--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European
Commission has granted marketing authorization for Vemlidy®
(tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for the
treatment of chronic hepatitis B virus (HBV) infection in adults and
adolescents (aged 12 years and older with body weight at least 35 kg).
The marketing authorization allows for the marketing of TAF in the 28
countries of the European Union, Norway and Iceland.
“As the first new treatment for chronic hepatitis B to be approved in
Europe in nearly a decade, this approval marks a step forward in the
management of a progressive, life-threatening disease affecting 13
million Europeans,” said Professor Pietro Lampertico, Head of the
Gastroenterology and Hepatology Division at the Fondazione IRCCS Ca’
Granda Ospedale Maggiore Policlinico, University of Milan, Italy.
“Treating a lifelong disease such as chronic hepatitis B can present
challenges as patients age, and the improvements in bone and renal
laboratory safety parameters demonstrated by TAF compared to TDF allow
it to provide an important new option for patients.”
TAF is a novel, targeted prodrug of tenofovir that has demonstrated
antiviral efficacy similar to Gilead’s Viread® (tenofovir
disoproxil fumarate, TDF) 245 mg, but at one-tenth the dose. Data show
that because TAF has greater plasma stability and more efficiently
delivers tenofovir to hepatocytes (cells of the liver) compared to TDF,
it can be given at a lower dose, which means there is less tenofovir in
the bloodstream. By reducing exposure to tenofovir, TAF is associated
with improved renal and bone laboratory safety parameters compared to
TDF in clinical trials.
“TAF reflects Gilead’s ongoing commitment to improve and simplify care
for people with chronic infectious diseases, including hepatitis B,
while we continue our research efforts for curative treatments,” said
Norbert Bischofberger, PhD, Executive Vice President, Research and
Development and Chief Scientific Officer, Gilead Sciences. “We look
forward to making TAF available as quickly as possible throughout the
TAF’s approval is supported by 48-week data from two international Phase
3 studies (Studies 108 and 110) in 1,298 adult chronic HBV patients.
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. Both studies met their primary endpoint of
non-inferiority to TDF based on the percentage of patients with chronic
hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of
therapy. Patients in the TAF arm of the trials also experienced
numerically higher rates of normalization of blood serum alanine
aminotransferase (ALT) levels. Both studies showed TAF and TDF to be
well-tolerated by patients and discontinuations due to adverse events
were 1% and 1.2%, respectively. The most common reported adverse events
with TAF were diarrhea, vomiting, nausea, abdominal pain, abdominal
distension, flatulence, fatigue, headache, dizziness, rash, pruritus,
increased ALT and arthralgia.
While the primary efficacy assessment was performed at week 48, data
show that at week 72 viral suppression as well as biochemical responses
were maintained with continued TAF treatment. The safety assessment
includes analyses performed at both week 48 and week 72 of treatment
(median duration of exposure of 88 weeks), and safety endpoints included
changes from baseline in bone mineral density at the hip and spine, and
changes from baseline in serum creatinine and in eGFR, key indicators of
renal health. In both studies, at weeks 48 and 72, changes in renal and
bone laboratory safety parameters favored the TAF treatment groups.
Vemlidy was approved by the U.S. Food and Drug Administration on
November 10, 2016 for the treatment of chronic HBV infection in adults
with compensated liver disease, and by the Japanese Ministry of Health,
Labour and Welfare on December 19, 2016 for the suppression of viral
replication in chronic hepatitis B patients with evidence of hepatitis B
virus replication and abnormal liver function.
For important safety information for TAF in Europe, including posology
and method of administration, special warnings, drug interactions and
adverse drug reactions, please see the European Summary of Product
Characteristics (SmPC) for Vemlidy, available from the EMA website at http://www.ema.europa.eu.
The full prescribing information for TAF in the United States, including
BOXED WARNING, is available at www.gilead.com.
Important Safety Information and Indication for
Vemlidy in the U.S.
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and
POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B
Lactic acidosis and severe hepatomegaly with steatosis, including
fatal cases, have been reported with the use of nucleoside analogs.
Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may
result in severe acute exacerbations of hepatitis B. Hepatic function
should be monitored closely with both clinical and laboratory
follow-up for at least several months in patients who discontinue
anti-hepatitis B therapy, including VEMLIDY. If appropriate,
resumption of anti-hepatitis B therapy may be warranted.
Warnings and Precautions
Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected
Patients: Due to this risk, VEMLIDY alone is not recommended for
the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have
not been established in HBV/HIV-1 coinfected patients. HIV antibody
testing should be offered to all HBV-infected patients before
initiating therapy with VEMLIDY, and, if positive, an appropriate
antiretroviral combination regimen that is recommended for HBV/HIV-1
coinfected patients should be used.
New Onset or Worsening Renal Impairment: Cases of acute renal
failure and Fanconi syndrome have been reported with the use of
tenofovir prodrugs. In clinical trials of VEMLIDY, there have been no
cases of Fanconi syndrome or proximal renal tubulopathy (PRT).
Patients with impaired renal function and/or taking nephrotoxic agents
(including NSAIDs) are at increased risk of renal-related adverse
reactions. Discontinue VEMLIDY in patients who develop clinically
significant decreases in renal function or evidence of Fanconi
Renal monitoring: Assess serum creatinine, serum
phosphorus, CrCl, urine glucose, and urine protein prior to initiating
and during therapy in all patients as clinically appropriate.
Most common adverse reactions (incidence ≥5%; all grades) were headache,
abdominal pain, fatigue, cough, nausea and back pain.
Coadministration of VEMLIDY with drugs that reduce renal function or
compete for active tubular secretion may increase concentrations of
tenofovir and the risk of adverse reactions.
Coadministration of VEMLIDY is not recommended with the following:
oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin,
rifapentine, or St. John’s wort. Such coadministration is expected to
decrease the concentration of tenofovir alafenamide, reducing the
therapeutic effect of VEMLIDY. Drugs that strongly affect P-gp and
BCRP activity may lead to changes in VEMLIDY absorption.
Consult the full prescribing information for VEMLIDY for more
information on potentially significant drug interactions, including
Dosage and Administration
Dosage: Adults; 1 tablet taken once daily with food.
Renal Impairment: Not recommended in patients with CrCl <15
Hepatic Impairment: Not recommended in patients with
decompensated (Child-Pugh B or C) hepatic impairment.
Testing prior to initiation: HIV infection.
VEMLIDY is indicated for the treatment of chronic hepatitis B virus
(HBV) infection in adults with compensated liver disease.
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,
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 may not see the benefits of prescribing Vemlidy.
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
The European SmPCs for Vemlidy and Viread are available from the EMA
website at www.ema.europa.eu.
Vemlidy and Viread 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 1-800-GILEAD-5 or 1-650-574-3000
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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Sung Lee, +1 650-524-7792
Kelsey Grossman, +1 650-378-2103