Novartis gains European Commission approval for RasitrioÂ®, a Rasilez-based triple combination pill to treat high blood pressure
Novartis International AG /
Novartis gains European Commission approval for RasitrioÂ®, a Rasilez-based
triple combination pill to treat high blood pressure
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* Pivotal phase III data showed significantly greater blood pressure
reductions with Rasitrio compared to dual combinations of each of its
* Up to 85 percent of patients may need multiple medications to help control
their high blood pressure underscoring the need for effective combination
Basel, November 28, 2011 - Novartis announced today that Rasitrio(Â®), the first
triple combination of aliskiren, amlodipine and hydrochlorothiazide (HCT) in a
single pill,(1) has received approval from the European Commission (EC) for the
treatment of high blood pressure.
"For the first time, high blood pressure patients in Europe with complex needs
will have access to a single pill combining the unique properties of Rasilez
with two well-established and effective high blood pressure treatments," said
David Epstein, Division Head of Novartis Pharmaceuticals. "Rasitrio is the first
Rasilez-based triple combination pill available in Europe to help patients
requiring multiple medications reach their treatment goal."
Rasitrio combines the first and only approved direct renin inhibitor (DRI)
worldwide, Rasilez, with the widely used calcium channel blocker amlodipine and
the diuretic hydrochlorothiazide. Rasilez is an important component of the
treatment as it targets renin for optimal control of the RAAS (renin angiotensin
aldosterone system), which is a key regulator of high blood pressure.
Rasitrio has been approved as substitution therapy for patients with high blood
pressure that are adequately controlled by the combination of the three
components at the same dose.
The approval of Rasitrio is based on pivotal phase III data involving more than
1,181 high blood pressure patients. The study showed that Rasitrio produced
statistically significant blood pressure reductions compared to dual
combinations of each of its individual components, including
aliskiren/amlodipine 300 mg/10 mg, aliskiren/HCTZ 300 mg/25 mg and
amlodipine/HCTZ 10 mg/25 mg. The effect of Rasitrio was observed as early as
one week after initiation of therapy and was maintained over the entire 24-hour
Up to 85 percent of high blood pressure patients may need several medications to
help them reach their goal,. However, the management of multiple drugs can
lead to compliance concerns, a major challenge for primary care physicians.
"Simplification of treatment for high blood pressure patients on three or more
therapies is key to improving patient compliance and outcomes," said Professor
Josep Redon, M.D., Hospital Clinico, University of Valencia, Spain. "This
innovative triple combination therapy, which has demonstrated significant
reductions in blood pressure during clinical trials, offers patients a new and
convenient treatment option."
The single pill combination Rasitrio works to lower blood pressure in three
ways. The Rasilez component 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. The calcium channel blocker amlodipine
lowers blood pressure by relaxing the blood vessel walls, and the diuretic
hydrochlorothiazide increases the excretion of sodium chloride and water. All
three complementary medicines enable blood to flow more easily, therefore
lowering blood pressure.
It is estimated that about one billion people globally have high blood
pressure,, with many remaining uncontrolled despite treatment. High
blood pressure alone can cause damage to the vital organs of the body, including
the heart, brain and kidneys. It is also linked with other conditions such as
diabetes, where high blood pressure is estimated to cause up to 75% of diabetic
cardiovascular complications. 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.
Tekturna/Rasilez is approved in over 80 countries. Aliskiren was approved in the
US and in the European Union in 2007 under the trade name of Tekturna and
Rasilez respectively. Rasilez received approval in Canada in 2008, Japan in
2009 and China in March 2010. Tekturna HCT(Â®), a single pill combination of
aliskiren and hydrochlorothiazide (HCT), was approved in the US in 2008 for
second-line treatment of high blood pressure, and in 2009 for first-line
treatment of high blood pressure. This single pill combination was approved for
add-on and replacement therapy in the European Union in 2009 under the tradename
Rasilez HCT(Â®). In 2009, Valturna(Â®), a single pill combination of aliskiren and
valsartan (Diovan(Â®)), was approved in the US. Tekamlo(Â®), the single pill
combination of aliskiren and amlodipine was approved in the US in August 2010
and in the European Union under the trade name Rasilamlo(Â®) in April 2011.
Amturnide(Â®), the triple combination of aliskiren, amlodipine and
hydrochlorothiazide (HCT), was approved in the US in December 2010.
Novartis has a strong cardiovascular and metabolic portfolio, focusing on
innovative treatments for high blood pressure and diabetes. These include
Diovan(Â®) (valsartan), the number one selling branded blood pressure medication
worldwide, Co-Diovan (valsartan and hydrochlorothiazide), a single-pill
combination of valsartan with the most widely prescribed diuretic. Exforge(Â®)
(valsartan/amlodipine), a single-pill combining two leading medicines for high
blood pressure; Exforge HCT(Â®) (amlodipine/valsartan/HCT); and Rasilez(Â®)
(aliskiren), the first and only approved direct renin inhibitor, and four
single-pill combinations of Rasilez(Â®), Tekamlo(Â®)/Rasilamlo(Â®
)(aliskiren/amlodipine), Amturnide (aliskiren/amlodipine/HCT), Tekturna
HCT(Â®)/Rasilez HCT(Â®) (aliskiren/HCT) and Valturna(Â®) (aliskiren/valsartan). For
the treatment of type 2 diabetes, these include Galvus(Â®) (vildagliptin, a DPP-
4 inhibitor) and Eucreas(Â® )(vildagliptin and metformin).
1. Sold in the US as Amturnide(Â®).
The foregoing release contains forward-looking statements that can be identified
by terminology such as "may," "will," "can," or similar expressions, or by
express or implied discussions regarding potential future revenues from
Rasitrio. 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 with Rasitrio to be materially different from any
future results, performance or achievements expressed or implied by such
statements. There can be no guarantee that Rasitrio will achieve any particular
levels of revenue in the future. In particular, management's expectations
regarding Rasitrio could be affected by, among other things, competition in
general; government, industry and general public pricing pressures; 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; unexpected manufacturing issues;
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
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2010, the Group's
continuing operations achieved net sales of USD 50.6 billion, while
approximately USD 9.1 billion (USD 8.1 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ approximately 121,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
Novartis is on Twitter. Sign up to follow @Novartis at
 Data on file. Novartis 2011 (Study SAH2302).
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Intervention for Endpoint Reduction in Hypertension Study (LIFE): a Randomised
Trial Against Atenolol. Lancet 2002;359:995-1003.
 Pepine CJ, 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.
 Rasitrio Summary of Product Characteristics (SmPC) for European Union.
 Rasilez Summary of Product Characteristics (SmPC) for European Union.
 Burnier M, et al. Medication adherence and persistence as the cornerstone of
effective antihypertensive therapy. Am J Hypertens 2006; 19:1190-6.
 Kearney P, et al. Global Burden of Hypertension: Analysis of Worldwide Data.
 Chobanian AV, et al. Seventh Report of the Joint National Committee on
Prevention, Detection Evaluation and Treatment of High Blood Pressure.
 Lloyd-Jones D, 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.
 El-Atat F, et al. Diabetes, Hypertension, and Cardiovascular Derangements:
Pathophysiology and Management. Curr Hypertens Rep 2004;6:215-23.
 IMS Midas Worldwide Sales Data 2010.
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