EAST HANOVER, N.J. — Novartis has received approval from the Food and Drug Administration for Amturnide tablets for the treatment of high blood pressure.
The company said Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).
According to Novartis, the triple-combination pill 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. The company said 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," stated Andre Wyss, president of Novartis Pharmaceuticals Corp. "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."
Hypertension affects nearly 75 million adults in the United States and about 1 billion adults worldwide, and an estimated 31% of adults being treated with antihypertensive medications are not at their blood pressure goal, Novartis reported. 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.
"Some patients require three or more medications to help manage their high blood pressure, which can be challenging and inconvenient," commented Alan 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."
