Novartis: Vital to ensure drug studies in excluded patient groups

Novartis has stated that it believes it is important for firms to study medications in patient groups that are usually not involved in standard clinical studies, including younger individuals.

This comment comes after the company’s treatment for high blood pressure, Diovan (valsartan) received a six-month extension of its marketing exclusivity by the US Food and Drug Administration (FDA) as a result of trials in children with the condition.

Consequently, the patent on the angiotensin receptor blocker has been extended from March 2012 to September 2012.

James Shannon, global head of development at Novartis Pharma, said: “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.”

While high blood pressure is more common in adults, affecting 30 per cent of people, almost five per cent of adolescents and children are reported to potentially also have the condition.

Following this announcement, the company expects a decision from the FDA on extending the indication of Diovan to include children by the end of the year.

Last month, Novartis presented new clinical trial data showing that administration with Diovan in conjunction with Rasilez (aliskiren) could result in additive blood pressure reduction in patients.