The European Commission approved Novartis' Rasitrio®, a single-pill combination therapy for hypertension that combines the firm’s direct renin inhibitor Rasilez/Tekturna (aliskiren) with the calcium-channel blocker amlopidine and the diuretic hydrochlorothiazide. The Rasitrio approval covers its use as substitution therapy for patients with high blood pressure that is adequately controlled by the combination of the three components at the same dose. The triple combination therapy was approved in the U.S. under the tradename Amturnide® in December 2010.
Regulatory clearance by the European regulator was based on pivotal Phase III trial data from over 1,181 patients demonstrating that Rasitrio therapy resulted in statistically significant blood pressure reductions compared with dual combinations of each of its individual components, including aliskiren/amlodipine 300 mg/10 mg, aliskiren/HCTZ 300 mg/25 mg, and amlodipine/HCTZ 10 mg/25 mg. Benefits of Rasitrio were observed as early as one week after initiation of therapy.
Tekturna/Rasilez is currently approved in over 80 countries. Tekturna HCT®/Rasilez HCT™ is a single-pill combination of aliskiren and hydrochlorothiazide, which is also approved in the U.S. and Europe. In 2009 Valturna®, a single-pill combination of aliskiren and valsartan (Diovan®), was approved in the U.S. Tekamlo®, the single-pill combination of aliskiren and amlodipine, was approved in the U.S. in August 2010 and in the European Union under the trade name Rasilamlo® in April 2011.