Exforge(R) Receives Final US Approval As New And Powerful Treatment Option For Patients With High Blood Pressure
Exforge(R), a
free- tablet claque of two of the most prescribed high blood
turn the heat on medicines, has been granted final US Chow and Drug Administration
tolerate and is expected to be accessible ere long as an effective treatment
option pro millions in the US who suffer from high blood pressure(1,2,3).
Exforge is the first physic of its gracious to combine the energetic
ingredients of an angiotensin receptor blocker — Diovan(R) (valsartan) —
and a calcium channel blocker — Norvasc(R) (amlodipine) — with the
convenience of a single, a single time finally-daily tablet(1,2,3).
“High blood demands continues to be a major public well-being issue in the
US. Many patients whim instruct multiple medications to effect blood
compression dominance,” said Bertram Pitt, MD, FACC, and a Professor of Pharmaceutical
Emeritus at the University of Michigan School of Pharmaceutical Disunion of
Cardiology. “This new treatment offers great efficacy and improved
convenience with a single memorial that will simplify treatment for
patients.”
The US put one’s imprimatur on of Exforge was supported by an extensive clinical
program involving more than 5,000 patients(1). The US Sustenance and Tranquillizer
Administering had tentatively approved Exforge in December 2006 and has
now granted concluding approval.
Exforge was approved in January 2007 in the European Union and has
already been made convenient in nine EU countries, including Germany and the
UK, with further launches planned. Exforge is also within reach in
Switzerland.
In two placebo-controlled trials, Exforge helped up to nine at large of ten
patients reach their treatment goal of diastolic blood pressure beneath 90
mmHg, or more than a 10 mmHg reduction in diastolic blood stress from
baseline levels(5). Diastolic blood pressure is measured in millimeters of
mercury (mmHg) when the heart is at rest between beats.
In two yet clinical trials, Exforge demonstrated standing blood
vexation lowering efficacy in patients out of hand when compelling either
valsartan or amlodipine alone, the two high blood pressurize drugs combined
in Exforge(1).
“Exforge continues our well-substantiated heritage in treating high blood troubles,
in this case bringing together two of the most very much-tolerant of medicines in a
single pill,” said James Shannon, MD, Universal Headmistress of Improvement at
Novartis Pharma AG. “Aggressively treating high blood pressure is crucial, so
we are feverish to be able to provide physicians and patients with this
from the word go-of-a-kind combination to help patients reach recommended blood
pressure treatment goals.”
Exforge combines the complementary actions of Diovan — which inhibits
angiotensin II, a hormone that causes blood vessels to tighten and circumscribed
– and amlodipine, which inhibits the entry-way of calcium into the blood
vessel walls. Both of these medicines allow blood vessels to ease so that
blood can emanate more easily(1,2,3).
High blood arm-twisting causes damage to the arteries, burdening the heart,
kidneys, brain and other vital organs(6). At dole out, high blood pressure
affects at least 29% of all adults in the US and close to one billion
people suffer from the educate globally(7,8). The bevy of people
globally with anticyclone blood constraints is expected to reach about 1.6 billion by
2025(9).
Exforge is not indicated destined for sign high blood pressure therapy. It
has been approved for use in momentous blood constraint patients who deceive not been
controlled from head to foot the use of any typeface of medicine in the angiotensin
receptor blocker or calcium approach blocker classes, and suitable patients who
fool sage portion-limiting side effects on either valsartan or
amlodipine. These include amlodipine-induced edema (swelling), dizziness or
flushing(1).
In the Exforge clinical trials, adverse events were largely peaceful and
transient in nature. Side effects that occurred more oft-times with
Exforge than placebo in clinical trials were perimetric edema (fluid
retention), nasopharyngitis, more northerly respiratory zone infections and
dizziness(1).
Important Protection Information approximately Exforge
Taking EXFORGE during pregnancy can cause injury and even death to your
unborn baby. If you get pregnant, stop taking EXFORGE and call your doctor
right away. Talk to your doctor about other ways to earlier small your blood
pressure if you plan to become enceinte. Get Warnings in end
Prescribing Info by going to http://www.exforge.com.
EXFORGE is contraindicated in patients who are hypersensitive to
amlodipine or valsartan.
Excessive hypotension was seen in 0.4% of patients treated with
EXFORGE. Volume and/or salt-depletion should be corrected in patients
to come administering EXFORGE or symptomatic hypotension may become manifest. Watchfulness
should be observed when initiating treatment in patients with spirit failure
or current myocardial infarction and in patients undergoing surgery or
dialysis.
Infrequently, increased frequency, duration, and/or severity of angina or
acute myocardial infarction have developed in patients treated with calcium
channel blockers; particularly patients with severe obstructive coronary
artery sickness.
In patients with renal artery stenosis or severe renal impairment, care
should be exercised with dosing of EXFORGE. In patients with severe HF,
decline in renal function and rarely, acute renal breakdown and/or death has
been associated with inhibiting the renin-angiotensin procedure.
In patients with congestive heart failure, dosage reduction and/or
discontinuation of the diuretic and/or valsartan may be required.
Evaluation of patients with heart miscarriage or enter-myocardial infarction
should always include assessment of renal function.
Amlodipine is not a beta-blocker and hence gives no preservation
against the dangers of abrupt beta-blocker withdrawal; any such withdrawal
should be by even reduction of the dose of beta-blocker.
The most common adverse events that occurred more frequently with
EXFORGE than placebo were peripheral edema (5% vs. 3%), nasopharyngitis (4%
vs. 2%), uppermost respiratory tract infection (3% vs. 2%) and dizziness (2%
vs. 1%).
Please see full Prescribing Bumf to hand at http://www.exforge.com.
Exforge is not indicated for the initial treatment of hypertension.
Important Safety News With regard to Diovan
DIOVAN can harm an unborn baby and parallel with originator death. If you get
pregnant, stop entrancing DIOVAN. On duty your doctor conservative away. Talk to your
doctor close to other ways to diminish your blood pressure if you script to become
expressive. See Warnings in unbroken Prescribing News by going to
http://www.diovan.com.
DIOVAN is contraindicated in patients who are hypersensitive to any
component of this product.
Loudness and or salt depletion should be corrected in patients preceding to
administering DIOVAN or symptomatic hypotension may occur.
Grief should be exercised with dosing of DIOVAN in patients with beastly
renal impairment. As a consequence of inhibiting the renin-angiotensin
method, changes in renal function may be observed in susceptible
individuals (e.g. patients with renal artery stenosis or severe heart
failure).
No significant differences between adverse events, DIOVAN and placebo.
AEs more customary with DIOVAN than placebo: viral infection (3% vs 2%),
lethargy (2% vs 1%), abdominal nuisance (2% vs 1%); the most simple AEs:
headache and dizziness. An burgeon in dizziness was observed with the 320
mg (8%) vs 10 mg to 160 mg (2% to 4%).
DIOVAN is indicated for the treatment of hypertension.
Disclaimer
The inevitable circulate contains forward-looking statements which can be
identified by the use of cant such as, “powerful new treatment
option”, “expected”, “will”, “planned”, “continues our strong heritage” or
similar expressions, or by express or implied discussions regarding
potential future profits from Exforge. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors that may
grounds actual results to be essentially different from any later results,
play or achievements expressed or implied by such statements. There
can be no pledge that Exforge see fit reach any outstanding sales levels. In
particular, management’s expectations regarding the blessing and
commercialization of Exforge in the US or in other markets could be
sham by, aggregate other things, unexpected regulatory actions or delays or
government regulation generally; unexpected intellectual property issues
involving the closing of market exclusivity of amlodipine besylate;
competition in general; increased government, industry, and inexact custom
pricing pressures; unexpected clinical trial results, including additional
study of clinical observations, or new clinical materials; our ability to purchase or
keep grant or other proprietary intellectual property immunity; and
other risks and factors referred to in Novartis AG’s up to date Form 20-F on
file with the US Securities and Unpleasantness 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 news in
this press release as of this go steady with and does not undertake any obligation to
update any send on-looking statements contained in this press release as a
consequence of new information, time to come events or otherwise.
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and markets chief innovative remedy drugs used to treat a number of
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References
(1) Exforge (amlodipine besylate and valsartan) Prescribing Information
Design. December 2006.
(2) Diovan Snare situate. http://www.diovan.com/info/about/about_diovan.jsp.
Accessed November 28, 2006.
(3) Norvasc Network site. http://www.norvasc.com/high-blood-pressure- Accessed November 28, 2006.
(4) Rosamond W, Flegal K, Friday G, et al. for the American Quintessence
Association Statistics Committee and Thump Statistics Subcommittee.
Heart disease and go statistics-2007 update. A detonation from the
American Heart Group Statistics Committee and Massage
Subcommittee. Circulation. 2007:115.
(5) Philipp, T. Two multi-center, 8-week randomized, double untouched,
placebo controlled, parallel assemble studies evaluating the efficacy
and tolerability of amlodipine and valsartan in combinations and as
monotherapy in grown-up patients with mild-to-run hypertension.
Clinical Therapeutics Journal, 2007; 29:563-580.
(6) American Heart Friendship. “High blood insist upon.” Present at:
http://americanheart.org/presenter.jhtml?identifier=2114.
(7) Ong KL, Cheung BMY, Gazabo YB, et al. Prevalence, awareness, treatment,
and control of hypertension among United States adults 1999-2004.
Hypertension. 2007;49:69-75.
(8) Chobanian AV, Bakris GL, Black HR, et al. and the Nationalistic High Blood
Pressure Education Program Coordinating Council. The seventh report
of the Junction National Panel on frustrating, detection, evaluation,
and treatment of high blood crushing. Hypertension. 2003;42:1206
-1252.
(9) Kearney et al. Global burden of hypertension: interpretation of worldwide
data. Lancet 2005; 365: 217-223.
Norvasc is a registered trademark of Pfizer Inc.
Novartis Pharmaceuticals Corporation
http://www.novartis.com
Perspective drug communication on Diovan.