Novartis Pharmaceuticals of East Hanover, N.J., has been granted pediatric exclusivity for Diovan (valsartan) based on studies conducted in children with high BP.
This extends marketing exclusivity for the valsartan compound patent by six months (from March to September 2012). Though high BP is more prevalent in adults (30%), it has been reported that nearly 5% of children and adolescents in the United States may have the condition.
“Novartis feels that wherever possible it is important to ensure that medications are studied in patient groups usually excluded from general clinical trials, such as younger people,” said James Shannon, MD, global head of development at Novartis Pharma AG.
Diovan is the only agent in the angiotensin receptor blocker class indicated to treat adults with high BP and heart failure as well as heart attack survivors. An FDA ruling on a possible indication to treat children and adolescents with high BP is anticipated by the end of the year.