Hypertension Drug Tekamlo (Aliskiren And Amlodipine) Approved By FDA

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Main Category: Hypertension
Also Included In: Regulatory Affairs / Drug Approvals;  Cardiovascular / Cardiology;  Pharma Industry / Biotech Industry
Article Date: 28 Aug 2010 - 6:00 PDT

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Novartis' single pill combination of aliskiren and amlopidine - Tekamlo - has been approved by the Food and Drug Administration (FDA) for the treatment of hypertension. Data revealed that Tekamlo significantly reduced blood pressure compared to amlodipine or aliskiren (Tekturna) alone. The medication has been approved in tablet form.

Novartis says Tekamlo - made up of aliskiren (Tekturna), the only approved direct rennin inhibitor, with a widely used calcium channel blocker, amlodipine - has been approved as initial therapy for individuals with high blood pressure who are likely to require multiple drugs. It has also been approved as replacement therapy for hypertensive patients whose blood pressure cannot be properly controlled with either aliskiren or amlodipine alone.

David Epstein, Division Head of Novartis Pharmaceuticals, said:

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. 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 approved Tekamlo after examining data on an eight-week, randomized, double-blind, placebo-controlled, multi-factorial clinical trial consisting of over 5,000 participants with mild-to-moderate hypertension (high blood pressure). The study demonstrated that Tekturna combined with amlodipine resulted in falls in systolic/diastolic blood pressure at trough of 14-17/9-11 mmHg, versus 4-9/3-4 mmHg for Tekturna alone, and 9-14/6-8 mmHg for amlodipine alone.

Iwo other double-blind, active-controlled trials of similar design involving patients with moderate-to-severe high blood pressure (SBP 160 - 200 mmHg), Tekamlo achieved considerably greater reductions in systolic and diastolic blood pressures when compared to amlodipine on its own.

In one study of 443 Black hypertensive 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 involving 484 participants, there was a treatment difference of 7.1/3.8 mmHg at endpoint between Tekamlo and amlodipine.

Tekamlo, as a single pill combination, lowers 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[1]. The blood pressure lowering effects of Tekamlo are largely attained within one to two weeks.

Alan Gradman, M.D., Professor of Medicine at Temple University School of Medicine, said:

Single-pill combination therapies provide a convenient treatment option while supporting physicians in addressing the complex needs of patients. 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.

Of the estimated 1 billion people worldwide with hypertension, a significant number are either untreated or do not reach their blood pressure target, Novartis informs. Hypertension can lead to damage to the heart, brain, kidneys and other vital organs. Controlled (treated) hypertension can reduce the risk of stroke and heart failure by nearly 50%, and heart attacks by 25%.

Source: Novartis, FDA

Written by Christian Nordqvist


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