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Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of a generic version of Letairis®1
(ambrisentan) Tablets, 5 mg and 10 mg, in the U.S.
Ambrisentan is an endothelin receptor antagonist indicated for the
treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to
improve exercise ability and delay clinical worsening. In combination
with tadalafil, ambrisentan is indicated to reduce the risks of disease
progression and hospitalization for worsening PAH, and to improve
exercise ability. For all female patients, ambrisentan tablets are only
available through a restricted program called the Ambrisentan Risk
Evaluation & Mitigation Strategy (REMS) due to the risk of fetal harm.
“The launch of ambrisentan tablets in the U.S. is an important addition
to Teva’s growing generic portfolio of nearly 60 cardiovascular
medicines,” said Brendan O’Grady, EVP and Head of North America
Commercial. “Our ability to help treat this disease is a testament to
our commitment to providing affordable, generic treatment options to
people living with chronic, life-long conditions.”
With nearly 500 generic medicines available, Teva has the largest
portfolio of FDA-approved generic products on the market and holds the
leading position in first-to-file opportunities, with over 100 pending
first-to-files in the U.S. Currently, one in eight generic prescriptions
dispensed in the U.S. is filled with a Teva generic product.
Letairis® has annual sales of nearly $247 million in the
U.S., according to IQVIA data as of February 2019.
About Ambrisentan Tablets
Ambrisentan tablets are indicated for the treatment of pulmonary
arterial hypertension (PAH) (WHO Group 1) to improve exercise ability
and delay clinical worsening. In combination with tadalafil, ambrisentan
tablets are indicated to reduce the risks of disease progression and
hospitalization for worsening PAH, and to improve exercise ability.
Studies establishing effectiveness included predominantly patients with
WHO Functional Class II–III symptoms and etiologies of idiopathic or
heritable PAH (60%) or PAH associated with connective tissue diseases
IMPORTANT SAFETY INFORMATION
WARNING: Embryo-Fetal Toxicity.
Do not administer ambrisentan
to a pregnant female because it may cause fetal harm. Ambrisentan is
very likely to produce serious birth defects if used by pregnant
females, as this effect has been seen consistently when it is
administered to animals.
Exclude pregnancy before the initiation
of treatment with ambrisentan. Females of reproductive potential must
use acceptable methods of contraception during treatment with
ambrisentan and for one month after treatment. Obtain monthly pregnancy
tests during treatment and 1 month after discontinuation of treatment.
Because of the risk of embryo-fetal toxicity, females can only
receive ambrisentan through a restricted program called the Ambrisentan
Ambrisentan is contraindicated in patients with Idiopathic Pulmonary
Fibrosis (IPF), including IPF patients with pulmonary hypertension (WHO
Group 3). Peripheral edema is a known class effect of endothelin
receptor antagonists, and is also a clinical consequence of PAH and
worsening PAH. In the placebo-controlled studies, there was an increased
incidence of peripheral edema in patients treated with doses of 5 or 10
mg ambrisentan compared to placebo. Peripheral edema/fluid retention is
more common with ambrisentan plus tadalafil than with ambrisentan or
tadalafil alone. Acute pulmonary edema during initiation of therapy with
vasodilating agents, such as ambrisentan, could be the possibility of
pulmonary veno-occlusive disease.
Decreased sperm counts have been observed in human and animal studies
with another endothelin receptor antagonist and in animal fertility
studies with ambrisentan. Ambrisentan may have an adverse effect on
spermatogenesis.Decreases in hemoglobin concentration and
hematocrit have followed administration of other endothelin receptor
antagonists and were observed in clinical studies with ambrisentan.
In clinical trials, the most common adverse reactions for ambrisentan
(>3% compared to placebo) were peripheral edema, nasal congestion,
sinusitis, and flushing. When used in combination with tadalafil, most
common adverse reactions (>5% compared with either monotherapy) were
peripheral edema, headache, nasal congestion, cough, anemia, dyspepsia,
For more information, please see accompanying Full
Prescribing Information, including the Boxed Warning. A copy may be
requested from Teva U.S. Medical Information at 888-TEVA-USA
or Teva’s Public Relations or Investor Relations contacts.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been
developing and producing medicines to improve people’s lives for more
than a century. We are a global leader in generic and specialty
medicines with a portfolio consisting of over 35,000 products in nearly
every therapeutic area. Around 200 million people around the world take
a Teva medicine every day, and are served by one of the largest and most
complex supply chains in the pharmaceutical industry. Along with our
established presence in generics, we have significant innovative
research and operations supporting our growing portfolio of specialty
and biopharmaceutical products. Learn more at www.tevapharm.com
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding the launch and potential benefits of the generic version of
, which are based on management’s
current beliefs and expectations and are subject to substantial risks
and uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from that
expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include risks
and other factors discussed in our Annual Report on Form 10-K for the
year ended December 31, 2018, including the sections thereof captioned
"Risk Factors." Forward-looking statements speak only as of the date on
which they are made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information.
1 Letairis® is a registered trademark of Gilead
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Source: Teva Pharmaceutical Industries Ltd.