Diovan HCT and Exforge Approved as First-Line Treatments for High Blood Pressure
Single-Pill Combinations Diovan HCT and Exforge Approved in US as First-Line Treatments for High Blood Pressure
Approvals consistent with current US treatment guidelines to start appropriate patients on combination therapies
EAST HANOVER, N.J., August 04, 2008 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved two single-pill combination medications, Diovan HCT (valsartan and hydrochlorothiazide) and Exforge (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, 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 (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.
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 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.
Please see full prescribing information about Diovan, Diovan HCT, Tekturna or Exforge at http://www.pharma.us.novartis.com or contact Christine Cascio at 862-778-8026 or . firstname.lastname@example.org
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.
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 , 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 http://www.novartis.com.
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Posted: August 2008
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- US Submission of Exforge Accepted for Review by the FDA - April 27, 2006