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FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent
Date:7/20/2009

essure patients. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) recommends that physicians consider starting their high blood pressure patients with two treatment agents, one of which should be a diuretic, if blood pressure is >20/10 mmHg above goal. The use of multiple medications may help patients achieve blood pressure goals in a more timely fashion.

"We are very pleased the FDA recognizes the benefit of Tekturna HCT for the first-line treatment of patients with moderately high blood pressure," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "Novartis is committed to supporting the research and development of effective treatments for high blood pressure that will help patients reach their blood pressure treatment goals."

Tekturna, a direct renin inhibitor, is the only drug that works by directly targeting renin and decreasing the activity of the RAAS. Renin is an enzyme produced by the kidneys that starts a process that makes blood vessels narrow and, when inappropriately activated, may lead to high blood pressure. Tekturna reduces renin activity and helps blood vessels relax and widen so blood pressure is lowered. Diuretics work to lower blood pressure by removing excess water and salt from the body.

Tekturna was approved in the US in 2007 as the first direct renin inhibitor. In 2008, Tekturna HCT was approved in the US for second-line treatment of high blood pressure. The long-term potential of Tekturna is being studied in an extensive clinical program, including outcomes trials, known as ASPIRE HIGHER.

Tekturna HCT is available in four strengths as tablets containing aliskiren and hydrochlorothiazide: 150 mg/12.5 mg tablets, 150 mg/25 mg tablets, 300 mg/12.5 mg tablets and 300 mg/25 mg tablets.

Study details

The FDA
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SOURCE Novartis Pharmaceuticals Corporation
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