Novartis' Diovan wins US pediatric exclusivity

The US Food and Drug Administration has granted Swiss drug major Novartis six months marketing exclusivity for Diovan (valsartan). The firm's antihypertensive was granted pediatric exclusivity based on data in children with high blood pressure, which extends the patent from March to September 2012.

Although high blood pressure is more prevalent in adults, affecting 30% of Americans, it has been reported that nearly 5% of children and adolescents in the USA may have the condition. An FDA decision on a possible indication to treat children and adolescents with high blood pressure is anticipated by the end of the year.

"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, global dead of development at Novartis Pharma AG.