Tekturna HCT®, a single-tablet combination of Tekturna®* and a
diuretic, receives US approval for treatment of high blood pressure
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* Tekturna HCT combines first approved direct renin inhibitor with
the diuretic hydrochlorothiazide (HCT) in a single tablet[1]
* Approved in more than 40 countries, Tekturna used alone lowers
blood pressure for 24 hours and beyond[2],[3]
* Data show combination of Tekturna and HCT resulted in significant
additional blood pressure reductions compared to either drug
alone[4]
* Many patients not at goal and most require two or more
medicines[5] - single-tablet combinations simplify treatment by
reducing number of pills patients take[6]
Basel, January 21, 2008 - Tekturna HCT® (aliskiren and
hydrochlorothiazide) has been approved by the US Food and Drug
Administration as a single-tablet combination of two high blood
pressure medicines - Tekturna® (aliskiren), the first new type of
high blood pressure medicine in more than a decade, and the diuretic
hydrochlorothiazide (HCT)[1].
The two medicines in this single-tablet combination work together to
lower blood pressure, with clinical data showing that the combination
of Tekturna and HCT offers greater blood pressure reductions than
either component alone[4].
This is the first regulatory approval of a single-tablet combination
therapy involving Tekturna, known as Rasilez® outside the US, which
has been shown to consistently lower blood pressure for 24 hours and
beyond[2],[3]. HCT, sometimes called a "water pill", is one of the
most commonly used high blood pressure medicines[7]. Tekturna HCT is
approved for patients not controlled by either medicine alone[1].
The efficacy of Tekturna for 24 hours and beyond is important because
many high blood pressure medicines fail to work around the clock,
especially during the early morning hours when blood pressure often
surges. Tekturna has also been shown to maintain blood pressure
reductions for up to four days after the last dose[8].
"Current guidelines call for aggressive treatment of high blood
pressure and many patients are still not controlled," said Alan
Gradman, MD, Division of Cardiovascular Diseases at the Western
Pennsylvania Hospital in Pittsburgh, USA. "Tekturna HCT offers
patients an effective new treatment option with significant blood
pressure reductions and improved convenience, by combining the
complementary mechanisms of action of the first direct renin
inhibitor and a diuretic in one tablet."
High blood pressure is estimated to affect nearly one in four adults
worldwide and remains uncontrolled in nearly 70% of people who have
this condition[5]. Most patients require two or more medicines to
reach their target blood pressure[5]. Single-tablet combinations such
as Tekturna HCT simplify high blood pressure management by reducing
the number of pills people take daily[6].
The US approval of Tekturna HCT was based on clinical trials
involving more than 2,700 patients treated with Tekturna and HCT[1].
Tekturna works by targeting renin and decreasing the activity of the
renin system as measured by plasma renin activity (PRA). By reducing
the effects of renin, Tekturna helps blood vessels to widen so blood
pressure is lowered. Diuretics work to lower blood pressure by
ridding the body of unneeded water and salt, but are also known to
increase PRA.
"Most patients need at least two medicines to control their high
blood pressure," said James Shannon, MD, Chief Medical Officer at
Novartis Pharma AG. "The rationale for combining a diuretic, which
raises plasma renin activity, with Tekturna, which counters this
increase, is compelling and unique, and Novartis is very proud to
introduce this innovative combination."
The most common side effects experienced by more patients taking
Tekturna HCT than those taking a placebo (or sugar pill) were
dizziness, flu-like symptoms, diarrhea, cough and tiredness.
The long-term potential of Tekturna and direct renin inhibition is
being studied in an extensive clinical program known as ASPIRE
HIGHER, which focuses on the effects of using Tekturna in patients
with cardiovascular or kidney disease.
Tekturna was discovered by Novartis and developed in collaboration
with Speedel.
Disclaimer
The foregoing release contains forward-looking statements which can
be identified by the use of terminology such as "will," "may" or
similar expressions, or by express or implied discussions regarding
the effectiveness of Tekturna HCT or Rasilez/Tekturna, potential
future regulatory filings or approvals of Tekturna HCT or
Rasilez/Tekturna or potential future sales of Tekturna HCT or
Rasilez/Tekturna. Such forward-looking statements reflect the current
views of Novartis regarding future events, and 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 that Tekturna HCT or Rasilez/Tekturna will
be approved in any additional markets or for any additional
indication in any market or that Tekturna HCT or Rasilez/Tekturna
will reach any particular sales levels. In particular, management's
expectations regarding Tekturna HCT or Rasilez/Tekturna could be
affected by, among other things, unexpected clinical trial results,
including unexpected additional analysis of clinical data, or
unexpected new clinical data; unexpected regulatory actions or delays
or government regulation generally; competition in general; increased
government, industry, and general public pricing pressures;
production delays or business interruption generally; our 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 AG provides healthcare solutions that address the evolving
needs of patients and societies. Focused solely on growth areas in
healthcare, Novartis offers a diversified portfolio to best meet
these needs: innovative medicines, cost-saving generic
pharmaceuticals, preventive vaccines and diagnostic tools, and
consumer health products. Novartis is the only company with leading
positions in these areas. In 2007, the Group's continuing operations
(excluding divestments in 2007) achieved net sales of USD 38.1
billion and net income of USD 6.5 billion. Approximately USD 6.4
billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 98,200 full-time associates and operate in over 140
countries around the world. For more information, please visit
http://www.novartis.com.
References
* Tekturna® is the US trade name for aliskiren. Aliskiren is known as
Rasilez® outside the US.
1. Tekturna HCT US Prescribing Information.
2. Oh BH, Mitchell J, Herron JR, et al. Aliskiren, an oral renin
inhibitor, provides dose-dependent efficacy and sustained 24-hour
blood pressure control in patients with hypertension. J Am Coll
Cardiol 2007;49:1157-1163.
3. Sica D, Gradman AH, Lederballe O, et al. Aliskiren, a novel renin
inhibitor, is well tolerated and has sustained BP-lowering effects
alone or in combination with HCTZ during long-term (52 weeks)
treatment of hypertension. Eur Heart J 2006;27(Suppl):121 P-797.
4. Villamil A, et al. Renin inhibition with aliskiren provides
additive antihypertensive efficacy when used in combination with
hydrochlorothiazide. Journal of Hypertension 2007, 25: 217-226
5. Ong KL, Cheung BMY, Man YB, et al. Prevalence, awareness,
treatment, and control of hypertension among United States adults
1999-2004. Hypertension 2007; 49:69-75.
6. Boolell M, Glasspool J. Cardiovascular Disease Health Burden,
Treatment Benefits and Challenges: Need for Partnership. Health &
Productivity Management Vol 5, No 4 December 2006, p 11-14.
7. Chobanian AV, Bakris GL, Black HR et al. and the National High
Blood Pressure Education Program Coordinating Committee. The seventh
report of the Joint National Committee on prevention, detection,
evaluation, and treatment of high blood pressure. Hypertension 2003;
42:1206-1252.
8. Herron J, et al. The Novel Renin Inhibitor Aliskiren Is Not
Associated With Rebound Effects On Blood Pressure Or Plasma Renin
Activity Following Treatment Withdrawal. Poster presented at American
Society of Hypertension Annual Session May 2006.
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