FDA approves Novartis' Tekamlo for treatment of high blood pressure

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 Novartis' commitment 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.

"Single-pill combination therapies provide a convenient treatment option while supporting physicians in addressing the complex needs of patients," said Alan H. Gradman, M.D., Professor of Medicine at Temple University School of Medicine. "This new single-pill combination demonstrated greater blood pressure reductions than either drug alone in clinical studies and therefore provides a new option to consider when choosing appropriate high blood pressure therapies."

Nearly 75 million -- or one in three -- US adults have hypertension. If left untreated, high blood pressure can lead to stroke, heart attack and heart failure. Tekamlo is not approved to treat or prevent stroke, heart attack and heart failure.

Of US adults being treated with high blood pressure medications, an estimated 31 percent do not have their blood pressure controlled to the recommended target of <140/90 mmHg. Research suggests that up to 85 percent of patients may need multiple medicines to achieve target levels of blood pressure control.

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 effective medicines, programs and an ongoing commitment to research.

Tekamlo is available in four strengths as once-daily tablets containing aliskiren and amlodipine:  150 mg/5 mg tablets, 150 mg/10 mg tablets, 300 mg/5 mg tablets and 300 mg/10 mg tablets.