FDA approves Tekturna HCT® as initial treatment in patients unlikely to achieve their blood pressure goal with a single agent

* Tekturna HCT combines the only approved direct renin inhibitor, Tekturna®, with widely used diuretic, hydrochlorothiazide, in a single pill[1]

* Data show combination of Tekturna and hydrochlorothiazide resulted in significant additional blood pressure reductions compared to either drug alone[1]

* Up to 85% of patients may require multiple medications to help control their blood pressure, underscoring the need for more effective combination treatments[2],[3]

* US guidelines recommend consideration for combination therapy as first-line therapy in patients unlikely to get to goal with a single agent[4]

Basel.- The US Food and Drug Administration (FDA) has 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 and only approved direct renin inhibitor[1], and the diuretic hydrochlorothiazide (HCTZ), one of the most commonly used high blood pressure medications[5].
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[1].
“Up to 85% of patients will need more than one medication to reach their blood pressure goals,” said Dr. Alan Gradman, 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.”
High blood pressure affects nearly one billion individuals globally[4] and is a major risk factor for cardiovascular disease, the number one leading cause of death worldwide[6]. If left untreated, patients with high blood pressure are at risk of cardiovascular events such as stroke, heart attack and heart failure, and of organ damage including kidney failure and vision problems[4]. Up to 65% of patients with high blood pressure do not have the condition under control[7].
Current US treatment guidelines support the first-line use of combination therapy in appropriate high blood pressure patients. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) recommends that physicians consider starting their high blood pressure patients with two treatment agents, one of which should be a diuretic, if blood pressure is more than 20/10 mmHg above goal4. The use of multiple medications may help patients achieve blood pressure goals in a more timely fashion[4].
“We are very pleased the FDA recognizes the benefit of Tekturna HCT for the first-line treatment of patients with moderately high blood pressure,” said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. “Novartis is committed to supporting the research and development of effective treatments for high blood pressure that will help patients reach their blood pressure treatment goals.”
About Rasilez/Tekturna
Tekturna, a direct renin-inhibitor, is the only drug that works by directly targeting renin to decrease the activity of the RAAS[1]. Renin is an enzyme produced by the kidneys that starts a process that narrows blood vessels 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[1]. Diuretics work to lower blood pressure by removing excess water and salt from the body[1].
The heart and kidney protection potential of Rasilez/Tekturna, independent of its blood pressure lowering ability, is currently being investigated further in the landmark ASPIRE HIGHER program, the largest ongoing cardio-renal outcomes program worldwide involving more than 35,000 patients in 14 trials.
Rasilez/Tekturna is approved in over 70 countries. Tekturna was approved in the US in March 2007 and in the European Union in August 2007 under the trade name Rasilez. In July 2009, Rasilez also received approval in Japan. Tekturna HCT, the first single-pill combination involving Tekturna, was approved in the US in January 2008 for second-line treatment of high blood pressure. The single-pill combination Rasilez HCT was approved in the European Union in January 2009. Other single-pill combinations with Rasilez are currently in development including a combination with Diovan and a single pill combination with amlodipine.
Novartis is focused on improving the lives of the hundreds of thousands of people with cardiovascular and metabolic diseases. As a global leader in cardiovascular and metabolic health for nearly 50 years, Novartis provides innovative therapies and support programs to treat high blood pressure and diabetes - both major public health issues. The portfolio includes the world’s most-prescribed angiotensin receptor blocker, the first and only approved direct renin inhibitor, a single pill combining two leading high blood pressure medicines, and a DPP-4 inhibitor.
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[1].
Study Details
The FDA approvals of Tekturna HCT were based on a clinical trial program involving over 6,200 patients and evaluated more than 2,700 patients exposed to combinations of Tekturna and hydrochlorothiazide. The safety and efficacy of Tekturna HCT were evaluated in patients with mild-to-moderate hypertension in an eight-week, randomized, double-blind, placebo-controlled, parallel-group, 15-arm factorial trial (n=2762). Patients were randomized to receive various combinations of Tekturna (75 mg to 300 mg) plus hydrochlorothiazide (6.25 mg to 25 mg) once daily (without titrating up from monotherapy) and followed for blood pressure response. The combination of Tekturna and hydrochlorothiazide resulted in additive placebo-adjusted decreases in systolic and diastolic blood pressure at trough of 10-14/5-7 mmHg at doses of 150-300 mg/12.5-25 mg, compared to 5-8/2-3 mmHg for Tekturna 150 mg to 300 mg and 6-7/2-3 mmHg for hydrochlorothiazide 12.5 mg to 25 mg alone. Blood pressure reductions with the combinations were greater than the reductions with the monotherapies. The safety and efficacy of Tekturna HCT as initial therapy was evaluated in this trial. All patients randomized to the combination groups received the combination treatment of Tekturna HCT at assigned doses as initial therapy without titration from monotherapy. The antihypertensive effect of Tekturna HCT was largely manifested within one week. The maximum antihypertensive effect was generally attained after about four weeks of therapy.