In clinical trials, the drug demonstrated clinically significant blood pressure reductions. 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.
Exforge utilizes two complementary mechanisms of action through the calcium channel blocker (CCB) amlodipine and the angiotensin receptor blocker (ARB) valsartan. According to the company, both agents are the most 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.”