Novartis' Diovan approved to treat children age 6 and up

EAST HANOVER, N.J. Novartis announced at the beginning of the week that the Food and Drug Administration approved its drug Diovan (valstartan) to treat high blood pressure in children and adolescents aged 6 to 16, according to published reports.

Diovan is an angiotensin receptor blocker. Angiotensin II causes the muscles surrounding the blood vessels to contract, which narrows the blood vessels.

There have been estimates that nearly five percent of children and adolescents may suffer from high blood pressure. Experts suggest that the increase in incidence of high blood pressure among children and adolescents is linked to the growing pediatric obesity epidemic. The National Health and Nutrition Surveys has found the percentage of overweight children increased from 13.8 percent to 16 percent between 1999 and 2004, while the share of overweight adolescents rose from 14 percent to 18.2 percent during the same period.

No relevant differences were identified between the adverse experience profile for pediatric patients aged six to 16 and that previously reported for adult patients. Total annual market sales for valsartan tablets were $1.3 billion as of July 2007, according to IMS Health