Diovan (valsartan) granted pediatric exclusivity by FDA

Aug 13 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 (30%), it has been reported that nearly five percent of children and adolescents in the US may have the condition. A FDA decision on a possible indication to treat children and adolescents with high blood pressure is anticipated by year end.

"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 adults not only with high blood pressure, but also those with heart failure and also heart attack survivors.

The need for high blood pressure medicines is strong given that the condition affects approximately 72 million adult Americans. Of those that 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.

Clinical studies have shown that Diovan effectively lowers blood pressure. Diovan specifically blocks a hormone that causes arteries to constrict, or tighten and narrow, an action that can cause high blood pressure.

In adults, Diovan is indicated for the treatment of hypertension when used alone or in combination with other high blood pressure agents. Diovan is also indicated for the treatment of heart failure (NYHA class II-IV). In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality.

Diovan is not indicated to prevent a heart attack or stroke resulting from hypertension.

Taking Diovan during pregnancy can cause injury and even death to an unborn baby. Women who plan to become pregnant, or are pregnant should stop taking DIOVAN and call their doctor right away.

Patients should not take DIOVAN if they are allergic to any of the ingredients in the product.

The most serious side effects with Diovan are low blood pressure (hypotension) and kidney problems. Other side effects with Diovan have generally been mild. In hypertensive patients, the most common side effects with Diovan are headache and dizziness.

The most common side effects of Diovan when used to treat people after a heart attack which cause them to stop taking the drug include low blood pressure, cough, rash and high blood creatinine (decreased kidney function). When used to treat people with heart failure, the most common side effects include dizziness, low blood pressure and diarrhea.