Novartis has been given the green light to market its triple combination antihypertensive Rasitrio.
The European Commission has approved Rasitrio as a single pill for the treatment of high blood pressure. It combines the Swiss major's direct renin inhibitor Rasilez/Tekturna (aliskiren), with the widely-used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide.
The approval of Rasitrio is based on Phase III data involving more than 1,181 patients which showed that the combo produced statistically significant blood pressure reductions compared to dual combinations of each of its individual components. Novartis quoted Josep Redon of Hospital Clinico, University of Valencia, Spain, as saying that “simplification of treatment for high blood pressure patients on three or more therapies is key to improving patient compliance and outcomes".
The Basel-headquartered group says that up to 85% of patients may need several medications to help them reach their goal but the management of multiple drugs "can lead to compliance concerns, a major challenge for primary care physicians". The combo was approved in the USA in December last year and is marketed there as Amturnide.
A couple of years ago, the US Food and Drug Administration approved Valturna, a single-pill combination of Tekturna and Novartis' Diovan (valsartan), though last September, the company decided not to pursue its bid to get approval in Europe due to the additional data regulators required. However another combo, Rasilamlo/Tekamlo (aliskiren and amlodipine), is now available on both sides of the Atlantic.