Novartis has announced that the new drug application for Exforge was accepted for standard review by the US Food and Drug Administration as a new treatment option for people with high blood pressure. The submission for EU approval was completed earlier in the year 2006.

In the clinical trials, Exforge demonstrated clinically significant blood pressure reductions. Exforge utilizes two complementary mechanisms of action through the calcium channel blocker amlodipine and the angiotensin receptor blocker valsartan. Both agents are the number 1 prescribed and 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.

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

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