Novartis receives FDA approval of Tekamlo

08-31-2010: The US Food and Drug Administration (FDA) approved Tekamlo® (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna® (aliskiren) with the widely used calcium channel blocker, amlodipine. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone.

"We welcome the FDA's decision to approve Tekamlo, as the treatment of high blood pressure remains a challenge for many patients requiring multiple medications to control their condition," said David Epstein, Division Head of Novartis Pharmaceuticals. "This approval reinforces the commitment of Novartis to cardiovascular research and to developing innovative and effective treatments for patients who have not reached their blood pressure goal."

The FDA approval of Tekamlo was based on clinical trial data involving more than 5,000 patients with mild-to-moderate high blood pressure. An eight-week, randomized, double-blind, placebo-controlled, multi-factorial study showed that the combination of Tekturna and amlodipine resulted in decreases in systolic/diastolic blood pressure at trough of 14-17/9-11 mmHg, compared to 4-9/3-4 mmHg for Tekturna alone, and 9-14/6-8 mmHg for amlodipine alone.

In two additional double-blind, active-controlled studies of similar design evaluating patients with moderate-to-severe high blood pressure (SBP 160 - 200 mmHg), Tekamlo demonstrated significantly greater reductions in systolic and diastolic blood pressures when compared to amlodipine alone. In one study of 443 Black patients the systolic/diastolic treatment difference between Tekamlo and amlodipine was 5.2/3.8 mmHg at the primary endpoint of eight weeks. In the other study of 484 patients the treatment difference between Tekamlo and amlodipine was 7.1/3.8 mmHg at endpoint.

The single-pill combination Tekamlo works to lower blood pressure in two 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 the blood vessel walls through the inhibition of calcium. Both of these medicines enable blood to flow more easily therefore lowering blood pressure. The blood pressure lowering effects of Tekamlo are largely attained within one to two weeks.