The US Food and Drug
Administration (FDA) has approved two single-pill combination medications,
Diovan HCT(R) (valsartan and hydrochlorothiazide) and Exforge(R)
(amlodipine and valsartan), as initial or ‘first-line’ therapies in
patients likely to need multiple drugs to achieve their blood pressure
goals.
The FDA approval of Diovan HCT and Exforge for first-line use
reinforces current US guideline recommendations to start appropriate
patients on combination therapy. Research suggests that up to 80% of
patients may need multiple medications to help them reach blood pressure
goals.
"These approvals provide flexibility and confidence to physicians to
use well-proven and well-accepted therapies as first-line treatment," said
Kenneth Jamerson, MD, Professor of Medicine, Department of Cardiovascular
Medicine, University of Michigan Healthcare System. "Patients may also
benefit by getting their blood pressure effectively and quickly under
control with a single pill and fewer co-pays."
With the approvals, healthcare professionals will have simplified
treatment strategies to help control high blood pressure with Diovan HCT
and Exforge. In patients who are likely to need multiple drugs to achieve
blood pressure goals, using single-pill combination medications first-line
will help eliminate the added steps of starting on a single medication,
increasing the dose and then adding on another medication.
The multiple steps often used in clinical practice may delay the time
it takes to reach blood pressure goals, which may create patient
frustration and a sense of failure. In addition, the first-line use of
single-pill combination medications in patients who are likely to need
multiple treatments to reach goal may reduce their pill burden and co-pays.
High blood pressure affects approximately 73 million adult Americans,
and one in four adults worldwide. It is one of the most important, but
treatable, risk factors for cardiovascular disease — the world’s leading
cause of death.
While it is easy to measure and can be successfully managed, nearly 40%
of people treated for high blood pressure do not have the condition under
control, underscoring the critical need for more effective treatment
regimens. If left untreated, patients with high blood pressure are at risk
of cardiovascular events, such as stroke, heart attack and heart failure,
as well as kidney failure and eye problems. Diovan HCT and Exforge are
approved to treat high blood pressure and are not approved to treat or
prevent stroke, heart attack, heart failure, kidney failure or eye
problems.
"We are very pleased that the FDA recognizes the therapeutic value and
the need of some patients to start therapy with a single-pill combination,"
said Trevor Mundel, MD, Head of Global Development Functions at Novartis
Pharma AG. "These approvals demonstrate our confidence in combination
medications for this therapeutic category, while reinforcing the Novartis
commitment to provide physicians with well-researched and effective
treatments for high blood pressure."
Diovan HCT combines in one tablet Diovan (valsartan), the world’s
number one selling branded high blood pressure medication, and
hydrochlorothiazide, a high blood pressure treatment from the diuretics
drug class. Exforge is the first treatment to combine Diovan (an
angiotensin receptor blocker, or ARB) and the calcium channel blocker (CCB)
amlodipine besylate, two of the most commonly prescribed high blood
pressure medications in their classes, into a convenient, once-daily single
tablet.
The Diovan HCT and Exforge first-line approvals were based on several
clinical trials in approximately 2,000 and 3,500 patients, respectively, in
which both products demonstrated efficacy and tolerability in patients with
mild-to-severe high blood pressure.
Diovan HCT was approved in the US in 1998 for second-line treatment of
high blood pressure and over five million patients have been prescribed the
medicine. Exforge was approved in 2007 and since its introduction last
year, over one million prescriptions have been filled.
Novartis is focused on improving the lives of the hundreds of millions
of people with cardiovascular and metabolic diseases. As a global leader in
cardiovascular and metabolic health for nearly 50 years, Novartis provides
innovative therapies and support programs to treat high blood pressure, a
major public health issue.
The core of the Novartis portfolio is its cardiovascular medications
for the treatment of high blood pressure. These include Diovan, the world’s
most-prescribed ARB, Tekturna(R) (aliskiren), the first and only approved
direct renin inhibitor, and Exforge, a single pill combining two leading
high blood pressure medicines. Novartis is dedicated to helping physicians
and patients improve cardiovascular and metabolic health through effective
medicines, programs and an ongoing commitment to research.
Diovan, Diovan HCT, Tekturna, and Exforge are prescription medications
for adults used to treat high blood pressure. They can be used alone or in
combination with other high blood pressure medications. It is not known
whether additional blood pressure reductions are present when Tekturna is
used in combination with ACE inhibitors or beta blockers. Exforge and
Diovan HCT may be used as the first medicine if your doctor decides you are
likely to need more than one medicine to lower your high blood pressure.
Important Considerations:
What is the most important information I should know about Diovan,
Diovan HCT, Tekturna, or Exforge?
If you become pregnant, stop taking Diovan, Diovan HCT, Tekturna, or
Exforge and call your doctor right away. Diovan, Diovan HCT, Tekturna, or
Exforge can harm an unborn baby causing injury and even death. If you plan
to become pregnant, talk to your doctor about other treatment options to
lower your blood pressure before taking Diovan, Diovan HCT, Tekturna, or
Buy generic soma Exforge.
Do not take Diovan HCT if you have a history of reduced urine output,
or have allergic reactions to certain drugs known as sulfonamides. Tell
your doctor about all your medical conditions and medicines you take,
including liver or kidney problems, lupus or if you take lithium.
Additionally, do not take Tekturna if you take cyclosporine.
Serious side effects could occur such as:
– low blood pressure
– kidney problems
– if you take Tekturna and develop an allergic reaction involving
swelling of the face, lips, throat, and/or tongue, which may cause
difficulty in breathing and swallowing stop taking the drug and contact
your doctor immediately.
– if you take Diovan HCT, a skin rash
– worsening chest pain with Exforge, especially in patients who already
have severe heart disease.
If you take Diovan HCT and have liver problems or lupus, these
conditions may get worse.
If you take Diovan HCT tell your doctor if you develop any of the
following signs of fluid and electrolyte problems: dry mouth, thirst, lack
of energy, weakness, drowsiness, restlessness, confusion, seizures, muscle
pain or cramps, muscle fatigue, very low urine output, fast heartbeat, or
nausea or vomiting.
Other side effects of Diovan, Diovan HCT, Tekturna, or Exforge have
generally been mild and brief. The most common side effects with Diovan and
Diovan HCT are headache and dizziness. A side effect experienced by more
patients taking Tekturna than patients taking a sugar pill was diarrhea.
Side effects that occurred more frequently with Exforge than placebo are
swelling of the hands, ankles, or feet; nasal congestion or sore throat;
head or chest cold; and dizziness.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "may", "could", "likely", "suggests",
"will", "risk", "confidence", or similar expressions, or by express or
implied discussions regarding potential future revenues from Diovan HCT and
Exforge. Such forward-looking statements reflect the current views of the
Company regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with Diovan
HCT and Exforge to be materially different from any future results,
performance or achievements expressed or implied by such statements. There
can be no guarantee that Diovan HCT and Exforge will achieve any particular
levels of revenue in the future. In particular, management’s expectations
regarding Diovan HCT and Exforge could be affected by, among other things,
the company’s ability to obtain or maintain patent or other proprietary
intellectual property protection; 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; 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 Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological, GI
and respiratory areas. The company’s mission is to improve people’s lives
by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS), which 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 98,000
full-time associates and operate in over 140 countries around the world.
For more information, please visit
Novartis Pharmaceuticals Corporation

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