The European Commission (EC) has granted Diovan (valsartan) a new paediatric indication for the treatment of hypertension in children and adolescents between 6-18 years of age.
Novartis Pharma claimed that following the EC’s decision, the paediatric indication needs to be implemented through EU National Competent Authorities before both the tablet and liquid forms of Diovan will be available across the EU.
Following national implementation, 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 Paediatric Regulation.
Germany’s Heidelberg University Hospital‘s professor of paediatrics and chief of the pediatric nephrology division Franz Schaefer said the only way to help reduce the impact of the condition in this patient group is to improve the identification and treatment of it.
Novartis 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, including Co-Diovan (valsartan / hydrochlorothiazide), Exforge (valsartan / amlodipine) and Exforge HCT (valsartan / amlodipine / hydrochlorothiazide).
Diovan was also approved for paediatric use in the US by the FDA in December 2008, for the treatment of children aged 6-16 years with high blood pressure.