FDA News

High Blood Pressure Medicine Diovan Gets Six Months Additonal Marketing Exclusivity from FDA

(Aug 09, 2007)-- Diovan (valsartan) has been granted pediatric exclusivity by the US Food and Drug Administration (FDA) based on studies conducted in children with high blood pressure. This action extends marketing exclusivity associated with the valsartan compound patent by six months 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 US may have the condition1. An FDA decision on a possible indication to treat children and adolescents with high blood pressure is anticipated by the end of 2007.

"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 its class (angiotensin receptor blocker or ARB) indicated to treat not only adults with high blood pressure, but also those with heart failure and heart attack survivors.

The need for high blood pressure medicines is strong given that the condition affects approximately 72 million adult Americans] and nearly a billion people worldwide. Of those who are being treated, more than 40% do not have the condition controlled. Uncontrolled high blood pressure has been shown in adults to increase the risk of heart attack and stroke, which are among the world's leading causes of death.

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