Novartis receives EU approval for 3-in-1 high blood pressure treatment

The European Commission has approved Novartis" Exforge HCT, a treatment for people with high blood pressure.

Exforge HCT combines in a once-daily single pill three blood pressure drugs: the angiotensin receptor blocker valsartan (Diovan), the calcium channel blocker amlodipine, and the diuretic hydrochlorothiazide (HCT).

In the EU, the drug 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 components 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 leading cause of death worldwide. Nearly 50% of Europeans suffer from high blood pressure and up to 85% of these patients may need multiple medications. The primary reason for hypertension treatment failure is non-compliance with the prescribed medication. Patients therefore may find it more convenient to take one single rather than multiple pills.

The US food and Drug Administration approved Exforge HCT in April this year for the second-line treatment of high blood pressure. It was approved in Switzerland in September for the treatment of patients whose blood pressure is not adequately controlled by dual therapy.