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Amlodipine Besylate-Valsartan Combo Accepted for FDA Review

EAST HANOVER, N.J., April 27 /PRNewswire/ -- Novartis announced today that the new drug application (NDA) for Exforge(R) (amlodipine besylate/valsartan) was accepted for standard review by the US Food and Drug Administration (FDA) as a new treatment option for people with high blood pressure. The submission for EU approval was completed earlier in 2006.

In clinical trials, Exforge demonstrated clinically significant blood pressure reductions. Exforge utilizes two complementary mechanisms of action through the calcium channel blocker (CCB) amlodipine and the angiotensin receptor blocker (ARB) valsartan. Both agents are the No. 1 prescribed branded medications in their respective classes.

More than 65 million Americans, or one in three adults, are estimated to have high blood pressure, with approximately 70% of them not under control. Among people who are treated for hypertension, approximately 50% are still estimated not to have achieved their treatment blood pressure goal.

"With so many patients still uncontrolled, a real need exists for an agent that can help people reach and maintain their blood pressure goal," said Dr. James Shannon, Head of Development, Novartis Pharma AG. "Exforge has the added benefit of bringing together the efficacy of two proven mechanisms of action, resulting in significantly lower blood pressure."

The US filing was based on a robust clinical trial program involving more than 5,000 hypertensive patients. The program included five controlled trials in which more than 2,600 patients received Exforge once daily. A single daily dose of Exforge provided clinically significant blood pressure reductions and was well tolerated.

Adverse events were generally mild and transient in nature. The most common side effects in clinical trials were peripheral edema, nasopharyngitis, upper respiratory tract infections and dizziness. The incidence of peripheral edema was statistically lower in people treated with Exforge than in people treated with amlodipine monotherapy. All drugs that act directly on the renin angiotensin system carry a warning that they should not be used in pregnant women due to risk of injury and even death to the unborn child.

High blood pressure is usually a lifelong condition that, while incurable, can be controlled with proper treatment. If left untreated, high blood pressure can have serious health consequences, including heart attack and stroke.

Source: Novartis

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