Rasilez receives EU approval

Novartis's Rasilez (aliskiren), the first new type of high blood pressure medicine in more than a decade, has been approved for use in the EU.

The European Commission approved Rasilez for the treatment of high blood pressure alone or in combination with other high blood pressure medicines, based on data from more than 7,800 patients in 44 clinical trials. The approval applies to all 27 EU member states plus Iceland and Norway.

Rasilez is the first in a new class of medicines called direct renin inhibitors. This new medication received its first approval in March 2007 from the US Food and Drug Administration under the brand name Tekturna, and has also been approved in Switzerland.

When used alone, Rasilez demonstrates greater blood pressure lowering than other commonly-used blood pressure medicines like angiotensin converting enzyme (ACE) inhibitors and the diuretic hydrochlorothiazide (HCT). For patients already taking other medicines, but not at their blood pressure goal, Rasilez provides additional blood pressure lowering when added to existing therapy. This additional benefit is seen when Rasilez is added to ACE inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers (CCBs) or HCT.

"Direct renin inhibition is the only major innovation in treating high blood pressure for more than a decade," said Dr James Shannon, global head of development at Novartis Pharma.

The long-term potential of Rasilez and direct renin inhibition is being studied in a clinical programme known as ASPIRE HIGHER, focusing on the benefits of using Rasilez in high blood pressure patients with heart failure or kidney failure. Data from the programme are expected to be released later this year.

Rasilez was developed in collaboration with Speedel.