FDA approves aliskiren/valsartan combo for HTN

Yael Waknine

September 22, 2009

Silver Spring, MD - The US Food and Drug Administration has approved a single-pill combination of the direct renin inhibitor aliskiren and the angiotensin-receptor blocker valsartan (Valturna, Novartis) for the treatment of hypertension in patients not adequately controlled on either drug alone and as initial therapy in patients likely to need multiple drugs to achieve their blood-pressure goals. The tablets will be available in 150/160-mg and 300/320-mg strengths.

"When it comes to diagnosing and treating high blood pressure, there is a real need for innovative therapies that help patients get to a healthier blood-pressure range," said Dr John Flack (Wayne State University, Detroit, MI) in a company news release. "Now for the first time, we have a treatment option in one pill that targets two key points of the [renin angiotensin aldosterone system], which may be overactive in many hypertensive patients."

The FDA's approval was based on data from a pivotal eight-week, randomized double-blind study showing that use of aliskiren/valsartan (150 mg/160 mg, titrated to 300 mg/320 mg at week 4) yielded significantly greater blood-pressure reductions from baseline compared with either drug alone or placebo (17.2/12.2 mm Hg vs 13.0/9.0 mm Hg, 12.8/9.7 mm Hg, and 4.6/4.1 mm Hg; p<0.05 for aliskiren/valsartan vs monotherapies and placebo).

Aliskiren and valsartan previously were approved as stand-alone products (Tekturna and Diovan, Novartis) and in combination with hydrochlorothiazide (Tekturna HCT and Diovan HCT, Novartis) for the treatment of hypertension.

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