FDA approves Novartis' Amturnide for treatment of high blood pressure

Novartis Pharmaceuticals CorporationDec 23 2010

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.

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 compared to aliskiren/amlodipine. In patients with severely elevated blood pressure, these reductions were greater by 16.3/8.2 mmHg, 9.6/4.8 mmHg, and 11.4/4.9 mmHg respectively.

"Some patients require three or more medications to help manage their high blood pressure, which can be challenging and inconvenient," said Alan H. Gradman, M.D., Professor of Medicine at Temple University School of Medicine. "The approval of Amturnide provides physicians with an effective treatment option that combines the benefits of the only approved direct renin inhibitor, a calcium channel blocker and a diuretic in one pill, while offering blood pressure reductions greater than two drugs alone."

The single-pill combination Amturnide works to lower blood pressure in three ways. The Tekturna component targets the activity of the renin angiotensin aldosterone system (RAAS), an important regulator of blood pressure. Tekturna directly binds to and inhibits renin, an enzyme produced by the kidneys that starts a process that can make blood vessels narrow and lead to high blood pressure. The calcium channel blocker amlodipine lowers blood pressure by relaxing muscles in the blood vessel walls, and the diuretic hydrochlorothiazide increases the excretion of sodium chloride and water. All three complementary medicines work to relax blood vessels and reduce blood volume, therefore lowering blood pressure.

High blood pressure affects nearly 75 million adults in the United States and about one billion adults worldwide. An estimated 31% of adults being treated with antihypertensive medications are not at their blood pressure goal. Large-scale clinical trials suggest that up to 85% of patients may need multiple medicines to achieve target levels of blood pressure control, and hypertensive patients with lower blood pressure goals or with substantially elevated blood pressure may require three or more medications.

If left untreated, high blood pressure increases the risk of stroke, heart attack and heart failure. Amturnide is not approved to treat or prevent stroke, heart attack and heart failure.

Novartis and Hypertension Management

For decades Novartis has been a leader and innovator in hypertension management, offering a range of innovative therapies designed to help patients with different needs achieve their blood pressure goals. Novartis is dedicated to helping physicians and patients improve cardiovascular and metabolic health through our ongoing commitment to researching effective medicines.

Amturnide is available in five strengths as once-daily tablets containing aliskiren, amlodipine and hydrochlorothiazide: 150 mg/5 mg/12.5 mg tablets, 300 mg/5 mg/12.5 mg tablets, 300 mg/5 mg/25 mg tablets, 300 mg/10 mg/12.5 mg tablets, and 300 mg/10 mg/25 mg tablets.