Novartis has submitted for European approval the new treatment Exforge (amlodipine and valsartan) to help people with high blood pressure that is estimated to affect at least 25% of all adults, by combining two of the leading blood pressure-lowering medicines in one tablet.
Exforge, a combination of the calcium channel blocker amlodipine and the angiotensin receptor blocker valsartan, has been shown in clinical trials involving more than 5,000 patients to provide powerful blood pressure control with excellent safety and tolerability, states a Novartis release.
Exforge is expected to help patients who struggle with the inconvenience of multiple medications while trying to reach their blood pressure goals. Significant reductions in both systolic and diastolic blood pressure were observed during the clinical trials, which also showed a lower incidence of peripheral edema (fluid retention) versus the use of amlodipine as a monotherapy.
Novartis is seeking approval for Exforge for use in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy, and as replacement therapy for patients taking amlodipine and valsartan as a free combination i.e. from separate tablets. A range of Exforge doses are planned to be made available following approval to help people with high blood pressure meet their treatment goals. In addition to the European Union, Exforge is on schedule to be submitted in 2006 for approval in the US as well as in other countries.
"About two-thirds of patients currently take two or more drugs to control their blood pressure. This can be very problematic since the burden of having to take multiple pills is one of the main contributors to poor compliance. Exforge offers the powerful efficacy of two very potent drugs, achieving significant blood pressure reductions with good tolerability and the convenience of a single pill," said James Shannon, head of development, Novartis Pharma AG.
"The combination of these highly efficacious and well-tolerated agents in a convenient single tablet is very exciting for patients and doctors. The dual mechanism of action is likely to provide patients with greater benefits over either therapy alone and should lead to improved compliance," said Professor Luis M. Ruilope, associate professor of internal medicine, head of hypertension unit, 12 de Octubre Hospital, Madrid, Spain.