FDA approves aliskiren/amlodipine combo for hypertension

August 28, 2010

Zurich, Switzerland - A drug for blood-pressure control that combines a direct renin inhibitor, aliskiren (Tekturna, Novartis), and a calcium-channel blocker, amlodipine, received approval yesterday from the US Food and Drug Administration (FDA) [1].

The newly approved single-pill medication (Tekamlo, Novartis Pharmaceuticals) is indicated for first-line therapy in patients who will likely need several drugs to achieve their blood-pressure goals and for replacement therapy in individuals who do not achieve such goals through a single medication such as aliskiren or amlodipine. It also is indicated as a substitute for its titrated components. According to the drugmaker, the drug produces blood-pressure-lowering effects within one to two weeks.

Four doses of the aliskiren/amlodipine combination will be marketed: 150 mg/5 mg, 150 mg/10 mg, 300 mg/5 mg, and 300 mg/10 mg.

The aliskiren/amlodipine combination was studied in 5549 patients with mild to moderate hypertension. Patients receiving the combination drug experienced significantly greater reductions in diastolic and systolic blood pressure than those who took either aliskiren or amlodipine alone, according to prescribing information published by the FDA.

In a placebo-controlled study, the overall incidence of adverse events with the new combination drug was similar to that of its individual components. A boxed warning on the label states that clinicians should discontinue the drug in women discovered to be pregnant because aliskiren can cause injury or death to a developing fetus.

More information about the approval of aliskiren/amlodipine is available on the FDA's website.


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