12/23/2009 - News

FDA Approves New Combination Blood Pressure Medication

By: June Chen, MD

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The U.S. Food and Drug Administration (FDA) has approved a single-pill combination of two medications, the direct renin inhibitor aliskiren and the angiotensin receptor blocker valsartan, for the treatment of high blood pressure.

This new combination pill, to be marketed as Valturna, is indicated for patients whose blood pressure is not adequately controlled on either medication alone and as first-line treatment for patients who are likely to need more than one drug to reach their blood pressure targets.

The FDA’s approval was based on data from a pivotal eight-week, randomized double-blind trial showing that use of aliskiren/valsartan led to significantly greater reductions in blood pressure compared with either drug alone or placebo. Aliskiren and valsartan were previously approved as single drugs, as well as in combination with the diuretic hydrochlorothiazide.
 
Valturna is the first blood pressure therapy to target two different points within the renin angiotensin aldosterone system, which plays a key role in regulating blood pressure.
 

Source:

Novartis Press Release, September 17, 2009.

 

Created on: 09/30/2009
Reviewed on: 12/23/2009

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