Rasilez HCT (aliskiren and hydrochlorothiazide) received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization as a new treatment for high blood pressure.
Rasilez HCT is a single-pill combination of two high blood pressure medicines - first-in-class direct renin inhibitor Rasilez (aliskiren) and the diuretic hydrochlorothiazide (HCT).
Rasilez HCT is twice as effective at reducing high blood pressure compared to HCT alone. Rasilez, known as Tekturna in the US, has been shown to consistently lower blood pressure beyond 24 hours. HCT, sometimes called a "water pill", is one of the most commonly used high blood pressure medicines.
Approximately 80 per cent of patients require two or more medications to control their high blood pressure. Single-pill combinations may offer patients with high blood pressure convenience and simplify treatment regimens.
One in four adults worldwide suffers from high blood pressure. The prevalence of high blood pressure is 60 per cent higher in Europe compared to North America and is the main risk factor for stroke, which claims 650,000 lives in Europe per year.
"Many patients who are suffering from high blood pressure are still not achieving their treatment goals. Therefore, it is critical that we continue to offer treatments that are effective and convenient," said Professor Rainer Düsing, MD, Faculty of Medicine, University of Bonn. "Studies have shown that single-pill combinations may increase treatment adherence by up to 20 per cent compared to free dose combinations of the same treatments. Rasilez HCT offers effective blood pressure lowering medications in one single pill - helping patients gain better control of their high blood pressure with the convenience of having to take only one pill."
The positive CHMP opinion recommends Rasilez HCT for use in patients not controlled by either medicine alone and for patients who are adequately controlled using Rasilez and HCT as separate medicines with the same dosing regimen offered in the single-pill combination. The opinion was based on clinical trials involving more than 2,700 patients and follows recent Swissmedic approval of Rasilez HCT and US Food and Drug Administration (FDA) approval in the US where it is known as Tekturna HCT.
"It is clear that patients with high blood pressure can benefit from more convenient treatment options that are effective and well tolerated," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "The complementary action of a direct renin inhibitor and a diuretic provides twice as much blood pressure lowering compared to the diuretic alone with the convenience of having to take only a single-pill. We are very pleased that the CHMP recognizes the beneficial value of Rasilez HCT and look forward to the European Commission decision in early 2009."
The heart and kidney protection potential of Rasilez/Tekturna, independent of its blood pressure lowering ability, is currently being investigated further in the landmark ASPIRE HIGHER program, the largest ongoing cardio-renal outcomes program worldwide involving more than 35,000 patients in 14 trials.
Rasilez/Tekturna is approved in 57 countries. Tekturna was approved in the US in March 2007 and in the European Union in August 2007 under the trade name Rasilez. Rasilez HCT was approved in Switzerland in October 2008 and a European Commission decision is expected for the single-pill combination in early 2009. Tekturna HCT, the first single-pill combination involving Tekturna, was approved in the US in January 2008.
Novartis is focused on improving the lives of the hundreds of millions of people with cardiovascular and metabolic diseases. As a global leader in cardiovascular and metabolic health for nearly 50 years, Novartis provides innovative therapies and support programs to treat high blood pressure and diabetes - both major public health issues. The portfolio includes the world's most-prescribed angiotensin receptor blocker, the first and only approved direct renin inhibitor, a single pill combining two leading high blood pressure medicines, and a novel DPP-4 inhibitor. Novartis is dedicated to helping physicians and patients through effective medicines, programmes and an ongoing commitment to research.