Novartis receives FDA approval of Tekamlo(TM), a single-pill combination of aliskiren and amlodipine to treat high blood pressure
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Novartis International AG / Novartis receives FDA approval of Tekamlo(TM), a single-pill combination of aliskiren and amlodipine to treat high blood pressure processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Tekamlo combines in a single-pill the only approved direct renin inhibitor,
Tekturna(®), with the widely prescribed calcium channel blocker,
amlodipine[1]
* Data showed Tekamlo significantly reduced blood pressure compared to
amlodipine or Tekturna alone[1]
* Up to 85 percent of patients may need multiple medications to help control
their high blood pressure, underscoring the need for effective combination
treatments[2,3]
Basel, August 27, 2010 - The US Food and Drug Administration (FDA) today
approved Tekamlo(®) (aliskiren and amlodipine) tablets, a single-pill for the
treatment of high blood pressure combining the only approved direct renin
inhibitor, Tekturna(® )(aliskiren) with the widely used calcium channel blocker,
amlodipine[1]. Tekamlo is approved as initial therapy for patients who are
likely to need multiple drugs to achieve their blood pressure goals, and as
replacement therapy for patients whose blood pressure is not adequately
controlled with either aliskiren or amlodipine alone[1].
"We welcome the FDA's decision to approve Tekamlo, as the treatment of high
blood pressure remains a challenge for many patients requiring multiple
medications to control their condition," said David Epstein, Division Head of
Novartis Pharmaceuticals. "This approval reinforces the commitment of Novartis
to cardiovascular research and to developing innovative and effective treatments
for patients who have not reached their blood pressure goal."
The FDA approval of Tekamlo was based on clinical trial data involving more than
5,000 patients with mild-to-moderate high blood pressure. An eight-week,
randomized, double-blind, placebo-controlled, multi-factorial study showed that
the combination of Tekturna and amlodipine resulted in decreases in
systolic/diastolic blood pressure at trough of 14-17/9-11 mmHg, compared to
4-9/3-4 mmHg for Tekturna alone, and 9-14/6-8 mmHg for amlodipine alone[1].
In two additional double-blind, active-controlled studies of similar design
evaluating patients with moderate-to-severe high blood pressure (SBP 160 - 200
mmHg), Tekamlo demonstrated significantly greater reductions in systolic and
diastolic blood pressures when compared to amlodipine alone[1].( )In one study
of 443 Black patients the systolic/diastolic treatment difference between
Tekamlo and amlodipine was 5.2/3.8 mmHg at the primary endpoint of eight
weeks[1]. In the other study of 484 patients the treatment difference between
Tekamlo and amlodipine was 7.1/3.8 mmHg at endpoint[1].
The single-pill combination Tekamlo works to lower blood pressure in two ways.
The Tekturna component targets the activity of the renin angiotensin aldosterone
system (RAAS), an important regulator of blood pressure[1]. Tekturna directly
binds to and inhibits renin, an enzyme produced by the kidneys that starts a
process that can make blood vessels narrow and lead to high blood pressure[1].
The calcium channel blocker, amlodipine lowers blood pressure by relaxing the
blood vessel walls through the inhibition of calcium. Both of these medicines
enable blood to flow more easily therefore lowering blood pressure[1]. The blood
pressure lowering effects of Tekamlo are largely attained within one to two
weeks[1].
"Single-pill combination therapies provide a convenient treatment option while
supporting physicians in addressing the complex needs of patients," said Alan
Gradman, M.D., Professor of Medicine at Temple University School of Medicine.
"This new single-pill combination demonstrated greater blood pressure reductions
than either drug alone in clinical studies and therefore provides a new option
to consider when choosing appropriate high blood pressure therapies."
It is estimated that about one billion people globally have high blood
pressure[4,5], and many of these remain either untreated or treated but are not
at their blood pressure target[6]. High blood pressure can cause damage to the
vital organs of the body, including the heart, brain and kidneys[5]. However, if
high blood pressure is properly controlled, the incidence of stroke and heart
failure can be reduced by almost half, and heart attacks by one quarter[5].
Tekturna/Rasilez(®) is approved in over 80 countries. Tekturna was approved in
the US in March 2007 and in the European Union in August 2007 under the trade
name Rasilez(®). In July 2009, Rasilez also received approval in Japan. Tekturna
HCT(®), a single-pill combination of aliskiren and hydrochlorothiazide, was
approved in the US in January 2008 for second-line treatment of high blood
pressure, and in July 2009 for first-line treatment of high blood pressure. The
single-pill combination Rasilez HCT(®) was approved in the European Union in
January 2009. In September 2009, Valturna(®), a single-pill combination of
aliskiren and valsartan (Diovan(®)), was approved in the US. Tekamlo(®), the
single-pill combination of aliskiren and amlodipine was submitted for European
approval in 2009. Other single-pill combinations with aliskiren are currently in
development including a single-pill combination with amlodipine and
hydrochlorothiazide.
Novartis has a strong cardiovascular and metabolic portfolio, focusing on
innovative treatments for high blood pressure and diabetes. These include
Diovan(®) (valsartan), the number one selling blood pressure medication
worldwide[7]. Exforge(®) (valsartan/ amlodipine), a single-pill combining two
leading medicines for high blood pressure; Exforge HCT(®)
(amlodipine/valsartan/HCT); and Rasilez(®) (aliskiren), the first and only
approved direct renin inhibitor, and two single-pill combinations of
Tekturna(®)/Rasilez(®), Tekturna HCT(®)/Rasilez HCT(®) (aliskiren/HCT) and
Valturna(®) (aliskiren/valsartan). For the treatment of type 2 diabetes, these
include Galvus(®) (vildagliptin, a DPP-4 inhibitor) and Eucreas(®) (vildagliptin
and metformin).
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "commitment," "in development," or similar expressions,
or by express or implied discussions regarding potential future approvals of
Tekamlo in additional markets, regarding the potential development of other
single-pill combinations with aliskiren, or regarding potential future revenues
from Tekamlo, Tekturna/Rasilez or other combination products containing
aliskiren. You should not place undue reliance on these statements. Such
forward-looking statements reflect the current views of management 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 Tekamlo will be approved for sale in any
additional markets. Nor can there be any guarantee that Novartis will
successfully develop any additional single-pill combination products containing
aliskiren. Neither can there be any guarantees that Tekamlo, Tekturna/Rasilez
or other combination products containing aliskiren will achieve any particular
levels of revenue in the future. In particular, management's expectations
regarding such products could be affected by, among other things, unexpected
regulatory actions or delays or government regulation generally; unexpected
clinical trial results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; competition in general;
government, industry and general public pricing pressures; the company's ability
to obtain or maintain patent or other proprietary intellectual property
protection; the impact that the foregoing factors could have on the values
attributed to the Novartis Group's assets and liabilities as recorded in the
Group's consolidated balance sheet, 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 provides healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 102,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
References
[1] Tekamlo (aliskiren and amlodipine) Tablets DRAFT Prescribing Information.
August 2010.
[2] Dahlof B, et al. Cardiovascular Morbidity and Mortality in the Losartan
Intervention for Endpoint Reduction in Hypertension Study (LIFE): a Randomised
Trial Against Atenolol. Lancet 2002;359:995-1003.
[3] Pepine CJ, Handberg EM, Cooper-DeHoff RM, et al. A Calcium Antagonist vs. a
Non-Calcium Antagonist Hypertension Treatment Strategy for Patients with
Coronary Artery Disease. The International Verapamil-Trandolapril Study
(INVEST): a Randomized Controlled Trial. JAMA 2003;290:2805-2816.
[4] Kearney P, et al. Global Burden of Hypertension: Analysis of Worldwide Data.
Lancet 2005;365:217-23.
[5] Chobanian AV, et al. Seventh Report of the Joint National Committee on
Prevention, Detection Evaluation and Treatment of High Blood Pressure.
Hypertension 2003;42:1206-1251.
[6] Lloyd-Jones D, Adams R, Brown T, et al. for the American Heart Association
Statistics Committee and Stroke Statistics Subcommittee. Heart disease and
stroke statistics-2010 update. A report from the American Heart Association
Statistics Committee and Stroke Statistics Subcommittee. Circulation.
2010;121;e46-e215.
[7] IMS Midas Worldwide Sales Data. December 2009.
# # #
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Datum: 27.08.2010 - 07:00 Uhr
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