Novartis Pharma claimed that following EC’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.
Following national implementation across the EU, Novartis plans 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.
Franz Schaefer, professor of pediatrics and chief of the pediatric nephrology division, Heidelberg University Hospital, 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. The only way to help reduce the impact of this condition in this patient group is to improve the identification and treatment of it.”
Novartis Pharma claimed that Diovan provides the flexibility of a wide range of single-pill combinations and dosing options, all with the convenience of a once-daily treatment schedule that include Co-Diovan (valsartan/hydrochlorothiazide), Exforge (valsartan/amlodipine) and Exforge HCT (valsartan/amlodipine/hydrochlorothiazide). 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.