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Novartis Gains FDA Approval for Amturnide™, a Triple-Combination Pill to Treat High Blood Pressure in Patients Uncontrolled on Two Medications
Date:12/22/2010

EAST HANOVER, N.J., Dec. 22, 2010 /PRNewswire/ -- Today Novartis announced that the US Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

The FDA approval was based on data from a double-blind, active controlled study, which showed that Amturnide provided significantly greater reductions in blood pressure compared to all dual combinations of its components. Amturnide is approved for patients whose blood pressure is not adequately controlled with any two of its individual components and is not indicated as initial therapy for high blood pressure. Amturnide is only the third high blood pressure treatment to combine three drugs in a single-pill.

"The FDA approval of Amturnide provides an important treatment option to help address the complex needs of high blood pressure patients," said Andre Wyss, President of Novartis Pharmaceuticals Corporation. "This approval emphasizes our commitment to cardiovascular research and to developing innovative and effective treatments for patients who have not reached their blood pressure goal."

The study involved 1,181 patients with moderately elevated blood pressure (mean systolic blood pressure [mSBP] 160-179 mmHg) or severely elevated blood pressure (mSBP >/=180 mmHg). Both patient populations achieved greater systolic and diastolic blood pressure reductions with Amturnide compared to dual combination treatment of aliskiren/amlodipine 300 mg/10 mg, aliskiren/HCTZ 300 mg/25 mg, and amlodipine/HCTZ 10 mg/25 mg.

In the overall patient population, Amturnide reduced systolic/diastolic blood pressure by an additional 9.9/6.3 mmHg compared to aliskiren/HCTZ; 7.2/3.6 mmHg compared to amlodipine/HCTZ; and 6.6/2.6 mmHg
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SOURCE Novartis Pharmaceuticals Corporation
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