FDA Approves Tekturna HCT to Treat Patients With High Blood Pressure

July 22, 2009 – The FDA this week approved Tekturna HCT (aliskiren and hydrochlorothiazide) tablets as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals.

Tekturna HCT is a single-pill combination of Tekturna (aliskiren), the first approved direct renin inhibitor, and the diuretic hydrochlorothiazide (HCTZ), one of the most commonly used high blood pressure medications.

The FDA approval of Tekturna HCT as initial therapy was based on clinical trial data involving more than 2,700 patients, which showed that treatment with the combination of Tekturna and HCTZ offered greater blood pressure reductions than either drug alone, said the manufacturer, Novartis Pharma AG.

"Up to 85 percent of patients will need more than one medication to reach their blood pressure goals," said Alan Gradman, M.D., cardiologist at The Western Pennsylvania Hospital and professor of medicine at Temple University. "This approval gives doctors the opportunity to aggressively treat their patients with a single-pill combination of the only approved drug, Tekturna, that works by directly targeting renin and decreasing the activity of the renin angiotensin aldosterone system (RAAS) and, HCTZ, a diuretic. This results in more significant blood pressure reductions, compared to taking either drug alone."

Hypertension affects nearly 74 million U.S. adults and is a major risk factor for cardiovascular disease, the number one leading cause of death in the U.S. If left untreated, patients with high blood pressure are at risk for cardiovascular events such as stroke, heart attack and heart failure. Of U.S. adults being treated, an estimated 36 percent are not at their blood pressure 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 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.

For more information: www.novartis.com