The European Commission (EC) has granted Diovan® (valsartan) a new pediatric indication for the treatment of hypertension in children and adolescents 6-18 years of age. Following the Commission's decision, the pediatric indication needs to be implemented through EU National Competent Authorities before Diovan will be available for pediatric use across the European Union (EU), both in the existing tablet formulations as well as a newly developed oral solution.
Following national implementation across the EU, Novartis intends to apply for a six-month exclusivity extension of the protection for valsartan (the active ingredient in Diovan), in line with the European Pediatric Regulation.
Evidence suggests that there are in fact more cases of pediatric high blood pressure in the EU than previously thought[1]. While the total number of children with high blood pressure in the EU is unknown, data from various EU countries suggest an average prevalence rate of up to 11%[2]. European Society of Hypertension (ESH) guidelines emphasize that high blood pressure in childhood and adolescence increases the risk of developing the condition in adulthood[3], which can subsequently lead to an increased risk of cardiovascular disease and damage to vital organs such as the heart and kidney[4].
"We are seeing an increasing number of children and adolescents being diagnosed with high blood pressure, a trend largely the result of the growing number of young people who are overweight or obese," said Franz Schaefer, MD, Professor of Pediatrics and Chief of the Pediatric Nephrology Division, Heidelberg University Hospital, Germany. "The only way to help reduce the impact of this condition in this patient group is to improve the identification and treatment of it."
Diovan was also approved for pediatric use in the United States by the Food and Drug Administration (FDA) in December 2008, for the treatment of children aged 6-16 years with high blood pressure[5].
Diovan is the world's number one selling high blood pressure medication[6]. It provides the flexibility of a wide range of single-pill combinations and dosing options, all with the convenience of a once-daily treatment schedule. These include Co-Diovan® (valsartan/hydrochlorothiazide), Exforge® (valsartan/amlodipine) and Exforge HCT® (valsartan/amlodipine/hydrochlorothiazide).
In addition to the valsartan family of products, the Novartis portfolio of cardiovascular and metabolic medications for the treatment of high blood pressure and diabetes includes the first and only approved direct renin inhibitor, Rasilez® (aliskiren), and its single-pill combination formulations, Rasilez HCT® (aliskiren/hydrochlorothiazide) and Valturna® (aliskiren/valsartan); and Galvus® (vildagliptin) and Eucreas® (vildagliptin/metformin) for the treatment of type 2 diabetes.
*Diovan is marketed under several trade names in EU countries
About NovartisNovartis 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 2009, the Group's continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com. [1] Lurbe E, et al. Management of high blood pressure in children and adolescents: recommendations of the European Society of Hypertension. J Hypertens 2009;27:1719-42.
[2] Gilardini L. Sympathoadrenergic and metabolic factors are involved in ambulatory blood pressure rise in childhood obesity. J Hum Hypertens 2008;22:75-82.
[3] Flynn JT. Hypertension in the young: epidemiology, sequelae and therapy. Nephrol Dial Transplant 2009;24:370-5.
[4] Flynn JT. Pediatric hypertension: recent trends and accomplishments, future challenges. Am J Hypertens 2008;21:605-12.
[5] Diovan® US Prescribing Information.
[6] IMS Midas Worldwide Sales Data. December 2009.