Novartis announced today
that the United States has become the first country in the world to approve
Tekturna(R) (aliskiren) tablets, the first new type of medicine in more
than a decade for treating high blood pressure -- a condition estimated to
affect nearly one billion people worldwide and remains uncontrolled in
nearly 70% of patients.
The Food and Drug Administration (FDA) issued the approval for Tekturna
as the first in a new class of drugs called direct renin inhibitors. A
once-daily oral therapy, Tekturna acts by targeting renin -- an enzyme
responsible for triggering a process that can contribute to high blood
pressure. This condition is a leading contributor to cardiovascular
disease, considered the world's leading cause of death.
Tekturna received FDA approval for treatment of high blood pressure as
monotherapy or in combination with other high blood pressure medications.
The use of Tekturna with maximal doses of ACE inhibitors has not been
adequately studied. Tekturna is expected to be available in March in
pharmacies as 150 mg and 300 mg tablets.
"Renin angiotensin system activity contributes to many of the
complications associated with high blood pressure," said Marc A. Pfeffer,
M.D., PhD, Professor of Medicine, Harvard Medical School and Cardiologist,
at Brigham & Women's Hospital. "By inhibiting this important system at its
origin, renin production, a direct renin inhibitor, such as Tekturna,
offers an exciting therapeutic option for treating hypertension."
In an extensive clinical trial program involving more than 6,400
patients, Tekturna provided significant blood pressure reductions for a
full 24 hours. Furthermore, Tekturna provided added efficacy when used in
combination with other commonly used blood pressure medications. In
clinical trials, the approved doses of Tekturna were generally well
tolerated and the most common side effect experienced by more patients
taking Tekturna than patients taking a sugar pill was diarrhea. Other less
common reactions to Tekturna include cough and rash.
Tekturna should be discontinued as soon as pregnancy is detected as it
may harm an unborn baby, causing injury and even death. Women who plan to
become pregnant should talk to their doctor about other treatment options
before taking Tekturna.
Angioedema has been rarely reported in patients taking Tekturna.
"Many patients require two or more medicines to control their blood
pressure. As a new treatment approach, Tekturna has the potential to help
these patients manage their disease," said James Shannon, MD, Global Head
of Development at Novartis Pharma AG. "Tekturna demonstrates our commitment
to developing innovative medicines to help the millions of patients
suffering from high blood pressure."
Novartis is committed to conducting a large outcome trial program to
evaluate the long-term effects of Tekturna and direct renin inhibition.
Disclaimer
The foregoing release contains forward-looking statements which can be
identified by the use of terminology such as "potential", "commitment to
developing", "committed to conducting", "to evaluate", "expected", "will
be", or similar expressions, or by express or implied discussions regarding
the long-term effects of Tekturna and direct renin inhibition, potential
future approvals of Tekturna, or future sales. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors
that may cause actual results to be materially different from any future
results, performance or achievements expressed or implied by such
statements. There can be no guarantee regarding the long-term effects of a
patient's use of Tekturna and direct renin inhibition. Nor can there be any
guarantees that Tekturna will be approved for sale in any additional
markets, or that it will reach any particular sales levels. In particular,
management's expectations regarding the approval and commercialization of
Tekturna could be affected by, among other things, unexpected clinical
trial results, including additional analysis of existing clinical data and
new clinical data; unexpected regulatory actions or delays or government
regulation generally; competition in general; increased government,
industry, and general public pricing pressures; the company's ability to
obtain or maintain patent or other proprietary intellectual property
protection; and other risks and factors referred to in Novartis AG's
current Form 20-F on file with the US Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should
underlying assumptions prove incorrect, actual results may vary materially
from those anticipated, believed, estimated or expected. Novartis is
providing the information in this press release as of this date and does
not undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information, future
events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological,
gastrointestinal and respiratory areas. The company's mission is to improve
people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in
offering medicines to protect health, treat disease and improve well-being.
Our goal is to discover, develop and successfully market innovative
products to treat patients, ease suffering and enhance the quality of life.
Novartis is the only company with leadership positions in both patented and
generic pharmaceuticals. We are strengthening our medicine-based portfolio,
which is focused on strategic growth platforms in innovation-driven
pharmaceuticals, high-quality and low-cost generics, human vaccines and
leading self-medication OTC brands. In 2006, the Group's businesses
achieved net sales of USD 37.0 billion and net income of USD 7.2 billion.
Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel,
Switzerland, Novartis Group companies employ approximately 101,000
associates and operate in over 140 countries around the world. For more
information, please visit novartis.
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