Novartis announces receival of EC grant for hypertension drug

Novartis has announced that The European Commission, or EC, has granted Diovan, or 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, or 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.

According to the company, evidence suggests that there are in fact more cases of pediatric High Blood Pressure in the EU than previously thought. 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%. European Society of Hypertension (ESH) guidelines emphasize that High Blood Pressure in childhood and adolescence increases the risk of developing the condition in adulthood, which can subsequently lead to an increased risk of cardiovascular disease and damage to vital organs such as the heart and kidney.

Diovan was also approved for pediatric use in the US by the FDA in December 2008, for the treatment of children aged 6-16 years with High Blood Pressure.

Franz Schaefer, professor of pediatrics and chief of the pediatric nephrology division, Heidelberg University Hospital, said: “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. The only way to help reduce the impact of this condition in this patient group is to improve the identification and treatment of it.”

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