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FDA Approves Diovan(R) for Treatment of High Blood Pressure in Children

- Nearly 5% of children and adolescents in U.S. may have high blood

pressure(1); increase in pediatric cases linked to growing obesity

epidemic(2,3) - Diovan has a proven safety profile in adults with high blood pressure

EAST HANOVER, N.J., Dec. 3 /PRNewswire/ -- Diovan(R) (valsartan), an angiotensin receptor blocker or ARB, has been approved following a priority review by the U.S. Food and Drug Administration (FDA) for the treatment of high blood pressure in children and adolescents ages six to 16.

High blood pressure has become a multigenerational health issue. Thirty percent of American adults are currently living with high blood pressure and now there are reports that nearly five percent of children and adolescents may have this condition(1).

Experts suggest that the increase in incidence of high blood pressure among children and adolescents is linked to the growing pediatric obesity epidemic(2,3). Based on the National Health and Nutrition Surveys (NHANES), the percentage of overweight children (six to 11 years old) increased from 13.8% to 16.0% between 1999 and 2004, while the share of overweight adolescents (12 to 19 years old) rose from 14.0% to 18.2% during the same period(4).

"Novartis believes it is important to provide physicians with treatment options such as Diovan which are effective in treating high blood pressure in this vulnerable population of children and adolescents," said John Orloff, MD, Senior Vice President, Medical and Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation.

No relevant differences were identified between the adverse experience profile for pediatric patients aged six to 16 and that previously reported for adult patients. Diovan is not indicated for treatment in children under six years old.

About Diovan

Clinical studies have shown that Diovan effectively lowers blood pressure. Diovan specifically blocks a hormone that causes arteries to constrict (tighten and narrow), an action that can cause high blood pressure.

In adults, Diovan is indicated for the treatment of hypertension when used alone or in combination with other high blood pressure agents. Diovan is also indicated for the treatment of heart failure (NYHA class II-IV). In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality.

Taking Diovan during pregnancy can cause injury and even death to an unborn baby. If you get pregnant, stop taking Diovan and call your doctor right away. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.

Do not take Diovan if you are allergic to any of the ingredients in this product.

Diovan is not recommended for treatment in children with glomerular filtration rate <30 mL/min/1.73 m(2).

The most serious side effects with Diovan are low blood pressure (hypotension) and kidney problems. Other side effects with Diovan have generally been mild. In hypertensive patients, the most common side effects with Diovan are headache and dizziness.

The most common side effects of Diovan when used to treat people after a heart attack which cause them to stop taking the drug include low blood pressure, cough, rash and high blood creatinine (decreased kidney function). When used to treat people with heart failure, the most common side effects include dizziness, low blood pressure and diarrhea.

Diovan is a prescription medication. Please see Important Product Information about Diovan at


The foregoing release contains forward-looking statements that can be identified by terminology such as "may," "suggest," or similar expressions, or by express or implied discussions regarding potential future revenue from Diovan. 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 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Diovan will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Diovan could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; 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, and other risks and factors referred to in the Novartis AG's current Form 20-F on file with the U.S. 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, gastrointestinal 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), a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit

(1) Sorof J, Lai D, Turner J, et al. Overweight, ethnicity and the

prevalence of hypertension in school-aged children. Pediatrics


(2) Ford ES, et al. Trends in Risk Factors for Cardiovascular Disease

Among Children and Adolescents in the United States. Pediatrics.


(3) Ogden CL, et al. Prevalence and Trends in Overweight Among US Children

and Adolescents, 1999-2000. JAMA. 2002;288:1728-1732.

(4) Hayman L, Meininger J, Daniels S, et al. Primary Prevention of

Cardiovascular Disease in Nursing Practice: Focus on Children and

Youth. A Scientific Statement From the American Heart Association

Committee on Atherosclerosis, Hypertension, and Obesity in Youth of

the Council on Cardiovascular Disease in the Young, Council on

Cardiovascular Nursing, Council on Epidemiology and Prevention, and

Council on Nutrition, Physical Activity, and Metabolism. Circulation

2007; 116; 344-357.

SOURCE Novartis Pharmaceuticals Corporation
Copyright©2007 PR Newswire.
All rights reserved

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