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Published on 23 October 2009

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Novartis receives approval in the EU for Exforge HCT

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The European Commission has granted Novartis marketing authorisation for Exforge HCT, a new 3-in-1 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 3-in-1 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% 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. Onerecent, large-scale study showed that approximately 75% 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, MD, 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, randomised, 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.

Study 2302 showed that triple therapy was more effective in reducing systolic and diastolic blood pressure than dual combinations of its components in patients with moderate-to-severe hypertension. Reductions in mean sitting systolic blood pressure of 40 to 50 mmHg were achieved, with up to 58% more patients receiving triple therapy achieving overall blood pressure control versus dual therapy (ie, blood pressure <140/90 mmHg).

The maximum dose of triple therapy (valsartan/amlodipine/HCT 10/320/25 mg) demonstrated additional reductions of 18-29% in systolic blood pressure and 19-32% in diastolic blood pressure when compared to all dual combinations of its components at the same doses. Ambulatory blood pressure monitoring showed that the blood pressure- lowering effect of triple therapy was maintained throughout the 24-hour period. In addition, the study showed that triple therapy was highly effective regardless of patients’ age, gender, race, ethnicity or baseline blood pressure, and was generally well tolerated versus dual therapy.

The core of the Novartis portfolio is its cardiovascular and metabolic medications for the treatment of high blood pressure and diabetes. These include Diovan (valsartan), the number one selling blood pressure medication worldwide; Exforge (valsartan/ amlodipine), a single pill combining two leading medicines for high blood pressure; Exforge HCT (valsartan/amlodipine/HCT); and Rasilez (aliskiren), the first and only approved direct renin inhibitor, and two single pill combinations of Rasilez, Rasilez HCT (aliskiren/HCT) and Valturna (aliskiren/valsartan). For the treatment of type 2 diabetes, these include Galvus (vildagliptin, a novel DPP-4 inhibitor) and Eucreas (vildagliptin and metformin).

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