FDA approves Exforge HCT® - the only high blood pressure treatment to
combine three medications in a single pill
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* Exforge HCT combines in one pill a calcium channel blocker,
angiotensin receptor blocker and diuretic (amlodipine, valsartan,
hydrochlorothiazide)
* In a clinical trial, Exforge HCT demonstrated significantly
greater reductions in systolic and diastolic BP, compared to all
dual combinations of its components[1]
* Up to 85% of patients may need multiple medications to help
control their blood pressure[2] and many need three or more[1]
* Exforge HCT can help appropriate patients reach BP goals; offers
convenience and potential cost savings by reducing up to three
co-payments to one
Basel, 30 April, 2009 - The US Food and Drug Administration (FDA) has
approved Exforge HCT, the only single pill to combine the three most
prescribed high blood pressure treatments in their classes in the
US[3]: the calcium channel blocker amlodipine, the angiotensin
receptor blocker valsartan, and the diuretic hydrochlorothiazide.
Exforge HCT is an important new option for patients who have tried
taking dual combinations of these classes of blood pressure
medications without success.
"The majority of people with hypertension will require more than one
medication to control their blood pressure and it's not uncommon for
patients with severe hypertension and/or patients requiring stricter
blood pressure control to need three or more medications," said David
A. Calhoun, MD, Professor of Medicine, Vascular Biology and
Hypertension Program, University of Alabama at Birmingham. "With a
triple combination option, appropriate patients may experience a
simpler routine of a convenient, once-daily pill to help them control
their high blood pressure."
Exforge HCT provides proven efficacy in patients with moderate to
severe hypertension (MSDBP 100 mmHg and <120 mmHg, MSSBP 145 mmHg and
<200 mmHg)[1]. In a clinical trial, the maximum dose of Exforge HCT
(amlodipine/valsartan/ hydrochlorothiazide 10 mg/320 mg/25 mg)
demonstrated additional reductions of 18-29% in systolic blood
pressure and 19-32% in diastolic blood pressure when compared to all
dual combinations of its components at the same doses[1],[4]. The
reductions in systolic/diastolic blood pressure with Exforge HCT were
7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide 320
mg/25 mg; 6.2/3.3 mmHg greater than with amlodipine/valsartan
10mg/320 mg; and 8.2/5.3 mmHg greater than with
amlodipine/hydrochlorothiazide 10 mg/25 mg[4]. These results also
include a placebo effect of unknown size. Ambulatory blood pressure
monitoring showed that the blood pressure lowering effect of Exforge
HCT was maintained throughout the 24-hour period[4].
High blood pressure affects approximately 74 million adults in the US
and one in four adults worldwide[5]. If high blood pressure is not
treated, it can lead to heart attack and stroke[6]. Exforge HCT is
not indicated for the treatment or prevention of heart attack or
stroke.
Research suggests that up to 85% of patients may need multiple
medications[2] and many need three or more[1] to help control their
blood pressure. Patients may find treatment more convenient with one
single pill rather than separate pills.
Exforge HCT contains three effective medicines that work in three
different ways[1]. A patient may be switched to the single pill
combination Exforge HCT if blood pressure is not adequately
controlled on any two of the following anti-hypertensive classes:
calcium channel blockers, angiotensin receptor blockers, and
diuretics[4]. The full blood pressure lowering effect was achieved
two weeks after being on the maximal dose of Exforge HCT[4].
"This approval of Exforge HCT as the only single blood pressure pill
combining the efficacy of three of the most-prescribed treatments in
their classes represents a significant milestone toward reducing the
burden of unmet need in hypertension," said Trevor Mundel, MD, Global
Head of Development at Novartis Pharma AG. "Novartis remains
confident in the important role of single pill combination
medications to help appropriate patients achieve their blood pressure
targets, while providing physicians with a range of powerful yet
flexible combinations of doses to effectively manage high blood
pressure in different patients."
Exforge and Exforge HCT will be offered at the same price in the US
on a dose equivalent basis, essentially providing the added diuretic
in Exforge HCT at no additional cost. Since Exforge HCT combines
three medications in a single pill, patients may benefit from reduced
insurance co-payments.
This FDA approval was based on a clinical trial of Exforge HCT of
over 2,000 patients[1]. Exforge HCT is currently under review in the
EU.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "may,' "can," "potential," "will,"
"suggests," "confident," or similar expressions, or by express or
implied discussions regarding potential additional approvals for
Exforge HCT or regarding potential future revenues from Exforge HCT.
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
Exforge HCT to be materially different from any future results,
performance or achievements expressed or implied by such statements.
There can be no guarantee that Exforge HCT will be approved for any
sale in any additional market. Nor can there be any guarantee that
Exforge HCT will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding Exforge
HCT 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 AG 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 2008, the
Group's continuing operations achieved net sales of USD 41.5 billion
and net income of USD 8.2 billion. Approximately USD 7.2 billion was
invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately
98,000 full-time-equivalent associates and operate in more than 140
countries around the world. For more information, please visit
http://www.novartis.com.
References
[1] Grosso, A., Jin J., Chen J. An 8-week, multi-centre, randomized,
double-blind, parallel-group study to evaluate the efficacy and
safety of the combination of valsartan/HCTZ/amlodipine compared to
valsartan/HCTZ, valsartan/amlodipine, and HCTZ/amlodipine in patients
with moderate to severe hypertension. Novartis Full Clinical Study
Report. 2008.
[2] Pepine CJ, Handberg EM, Cooper-DeHoff RM, et al, for the INVEST
Investigators. 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.
[3] IMS MIDAS sales data. February 2008 -January 2009
[4] Exforge HCT US Product Information. April 2009
[5] Lloyd-Jones, D., Adams, R, Carnethon, M. et al. Heart Disease and
Stroke Statistics 2009 Update. A Report from the American Heart
Association Statistics Committee and Stroke Statistics Committee.
Circulation. 2009; ICD-9 401-404, ICD-10 I10-I15.
[6] CDC High Blood Pressure Fact Sheet. June 2005.
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