European Regulator Approves Novartis’ Rasilez

September 5, 2007

Novartis’ new first-in-class blood pressure drug, Rasilez, has been approved in the European Union, the company announced Aug. 27.

The European Commission approved Rasilez (aliskiren) for the treatment of high blood pressure, alone or in combination with other hypertension medicines, based on data from more than 7,800 patients in 44 clinical trials. The drug was approved in the U.S. in March as Tekturna. It has also been approved in Switzerland.

Rasilez is the first in a new class of medicines called direct renin inhibitors, Novartis said. It acts by directly inhibiting renin, an enzyme that triggers a process that can lead to high blood pressure.

When used alone, Rasilez has demonstrated greater blood pressure lowering than other commonly used blood pressure medicines such as angiotensin converting enzyme (ACE) inhibitors and the diuretic hydrochlorothiazide (HCT), Novartis said. For patients already taking other medicines, Rasilez provides additional blood pressure lowering when added to ACE inhibitors, angiotensin II receptor blockers, calcium-channel blockers or HCT.