Novartis has submitted for European approval the new treatment Exforge (amlodipine and valsartan) for high blood pressure 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.
According to the company 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.
Data from clinical trials involving Exforge are planned to be released at the American Society of Hypertension meeting in May 2006.
"The combination of these highly efficacious and well-tolerated agents in a convenient single tablet is very exciting for patients and doctors," said Professor Luis M. Ruilope, Associate Professor of Internal Medicine, Head of Hypertension Unit, 12 de Octubre Hospital, Madrid, Spain. "The dual mechanism of action is likely to provide patients with greater benefits over either therapy alone and should lead to improved compliance," he added.