Novartis gains FDA approval for Amturnid, a triple-combination pill to treat high blood pressure in patients uncontrolled on two medications
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.
- (1888PressRelease) December 24, 2010 - 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 (mSBP >/=180 mmHg). Both patient populations achieved greater systolic and diastolic blood pressure reductions with Amturnide compared to dual combination treatment of aliskiren/amlodipine 300 mg/10 mg, aliskiren/HCTZ 300 mg/25 mg, and amlodipine/HCTZ 10 mg/25 mg.
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.
AMTURNIDE is indicated for the treatment of hypertension. AMTURNIDE is not indicated for initial therapy of hypertension.
Use AMTURNIDE for patients not adequately controlled with any two of the following: aliskiren, dihydropyridine calcium-channel blockers (DHP-CCB), and thiazide diuretics.
Switch a patient who experiences dose-limiting adverse reactions attributed to an individual component-while on any dual combination of components of AMTURNIDE- to AMTURNIDE at a lower dose of that component to achieve similar blood pressure reductions.
AMTURNIDE may be substituted for its titrated components.
Safety and efficacy of AMTURNIDE in pediatric patients have not been established.
IMPORTANT SAFETY INFORMATION
WARNING: AVOID USE IN PREGNANCY
When pregnancy is detected, discontinue AMTURNIDE as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and even death to the developing fetus. [See WARNINGS and Precautions (5.1) and Use in Special Populations (8.1)].
Angioedema: Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with aliskiren and has necessitated hospitalization and intubation. This may occur at any time during treatment and has occurred in patients with and without a history of angioedema with ACE inhibitors (ACEI) or angiotensin receptor antagonists. Discontinue AMTURNIDE immediately in patients who develop angioedema and do not readminister.
Hypotension: Excessive hypotension was seen rarely (0.3%) in patients with uncomplicated hypertension treated with AMTURNIDE in a controlled trial. Volume- and/or salt-depletion should be corrected in patients prior to administration of AMTURNIDE or symptomatic hypotension may occur.
Risk of MI or Angina: Rarely, initiation or change to the dose of a calcium channel blocker has resulted in the increased frequency, duration, or severity of angina or acute myocardial infarction, particularly in patients with severe obstructive coronary artery disease.
Renal Considerations: In patients with severe renal impairment (GFR