FDA Approves Novartis’ Tekturna HCT Tablets

The FDA has approved Novartis’ Tekturna HCT (aliskiren and hydrochlorothiazide) tablets, as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals.

The FDA approval was based on clinical trial data involving more than 2,700 patients. The result showed that treatment with the combination of Tekturna and HCTZ offered greater blood pressure reductions than either drug alone.

Alan Gradman, Cardiologist at the Western Pennsylvania Hospital and Professor of Medicine at Temple University, said: 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.

Trevor Mundel, Global Head of Development at Novartis, said: We are very pleased the FDA recognizes the benefit of Tekturna HCT for the first-line treatment of patients with moderately high blood pressure.