Novartis wins European approval for triple blood pressure pill

Novartis has been granted approval by the European Commission for Rasitrio, a triple combination pill for high blood pressure.

Rasitrio combines Novartis' proprietary renin inhibitor Rasilez/Tekturna (aliskiren) with two generic antihypertensive drugs, the calcium antagonist amlodipine and diuretic hydrochlorothiazide. It was approved in the US as Amturnide a year ago.

It has been approved as substitution therapy for patients with high blood pressure that are adequately controlled by the combination of the three components at the same dose, according to Novartis.

The company notes that up to 85 per cent of blood pressure patients require multiple medications to reach treatment targets, and compliance with therapy is a "major challenge for primary care physicians".

"Simplification of treatment for high blood pressure patients on three or more therapies is key to improving patient compliance and outcomes," commented Professor Josep Redon of the Hospital Clinico, University of Valencia, Spain.

Faced with patent expiration for its top-selling Diovan (valsartan) blood pressure drug - which brought in $4.48bn in the first nine months of the year - Novartis has been turning to Rasilez and its line extensions to help soften the blow of generic competition, which has already started in a number of EU countries, as well as Canada and Brazil.

First launched in 2007, Rasilez sales grew 47 per cent to $305m in the first three quarters of 2011, helped by the introduction of dual combinations with other drugs.

Rasilez HCT (aliskiren and hydrochlorothiazide) reached the market in 2008, and was followed in the US only by a valsartan/aliskiren combination - called Valturna - in 2009. Novartis elected not to pursue development of the latter product in Europe after the EMA asked for additional information. A combination of aliskiren and amlodipine was approved in 2010 in the US as Tekamlo and in the EU as Rasilamlo earlier this year.

"For the first time, high blood pressure patients in Europe with complex needs will have access to a single pill combining the unique properties of Rasilez with two well-established and effective high blood pressure treatments," said David Epstein, division head of Novartis Pharmaceuticals.