The European Commission has granted Novartis marketing authorization for Exforge HCT, a new three-in-one treatment for people with high blood pressure.

Exforge HCT combines in a once-daily single pill the efficacy of three widely prescribed blood pressure medications: the angiotensin receptor blocker valsartan (Diovan), the calcium channel blocker amlodipine, and the diuretic hydrochlorothiazide (HCT). All three have been used extensively for many years in patients with hypertension.

"Novartis is committed to helping patients improve their treatment compliance. Simplified treatment regimens and reduced pill burdens have been shown to help achieve this," said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division. "We are pleased that with the approval of Exforge HCT, a new three-in-one treatment for high blood pressure is now available to patients in the EU. With Diovan as the foundation of this new therapy, we are confident that it will become an important new treatment option."

In the EU, Exforge HCT is indicated for substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of valsartan, amlodipine and HCT, taken either as three single-component formulations or as a dual-component and a single-component formulation.
High blood pressure, or hypertension, is one of the most important but treatable risk factors for cardiovascular disease - the number one cause of death worldwide. Nearly half of Europeans suffer from high blood pressure and up to 85 per cent of these patients may need multiple medications to help reach treatment goals. The primary patient-related factor for hypertension treatment failure is non-compliance with the prescribed antihypertensive medication. Patients therefore may find treatment more convenient with one single pill rather than multiple separate pills. One recent, large-scale study showed that approximately 75 per cent of patients achieved their blood pressure treatment goal after switching to a single-pill combination therapy.

"It is not uncommon for patients with severe hypertension, or those requiring stricter blood pressure control, to need three or more medications," said professor Rainer Düsing, of the Faculty of Medicine, University of Bonn, Germany. "Now that this new single-pill triple-combination option is available, appropriate patients may find it easier to comply with their prescribed treatment regimens involving a once-daily single pill versus multiple medications, especially if it has also been proven to be highly effective at helping patients reach their blood pressure goals."

Exforge HCT was approved in the United States by the Food and Drug Administration (FDA) in April 2009 for the second-line treatment of high blood pressure. It was approved in Switzerland in September 2009 for the treatment of patients whose blood pressure is not adequately controlled by dual therapy.

The EU approval was supported by the results of Study 230211, a multinational, randomized, double-blind, parallel-group, phase-III study designed to compare the efficacy and safety of triple therapy (valsartan, amlodipine and HCT) with the various dual combinations of its components - valsartan/HCT, amlodipine/valsartan or amlodipine/HCT - in patients with moderate-to-severe hypertension. The trial was conducted in 15 countries, with 2,271 patients randomized to double-blind treatment.