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 EU, both in the existing tablet formulations as well as a newly developed oral solution.

The company said that following national implementation across the EU, it 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.

Diovan was also approved for pediatric use in the US by the Food and Drug Administration (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 of Heidelberg University hospital at Germany, 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.”

Will Novartis benefit with the new pediatric investigation?

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