-- Vemlidy® is the First New
Treatment for Chronic Hepatitis B Infection to be Approved in the
European Union in Nearly a Decade --
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 European Union.”
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 syndrome.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.
Adverse Reactions
Most common adverse reactions (incidence ≥5%; all grades) were
headache, abdominal pain, fatigue, cough, nausea and back pain.
Drug Interactions
- 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
clinical comments.
Dosage and Administration
- Dosage: Adults; 1 tablet taken
once daily with food.
- Renal Impairment: Not
recommended in patients with CrCl <15 mL/min.
- Hepatic Impairment: Not
recommended in patients with decompensated (Child-Pugh B or C)
hepatic impairment.
- Testing prior to initiation: HIV
infection.
Indication
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, 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 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 forward-looking
statements.
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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Gilead Sciences, Inc.InvestorsSung Lee, +1 650-524-7792orMedia
(U.S.)Kelsey Grossman, +1 650-378-2103
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