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FDA approval for blood pressure pill

Novartis has won US Food and Drug Administration approval for a combination high blood pressure therapy called Tekamlo

Novartis has won US Food and Drug Administration (FDA) approval for a high blood pressure therapy called Tekamlo. It is a single-pill combination of the company's renin inhibitor Tekturna (aliskiren) and the calcium channel blocker amlodipine, which is the active ingredient in Pfizer's top-selling high blood pressure medication Norvasc.

The Tekamlo approval allows the new drug to be marketed in the US 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 Tekturna or amlodipine alone.

Novartis' marketing application for the combination product included clinical trial data from studies involving more than 5,000 patients with mild-to-moderate high blood pressure. The studies showed that the once-a-day combination therapy provided greater benefits than either drug alone and that the blood pressure lowering effects were largely attained within one to two weeks.

Tekturna has been marketed by Novartis in the US since 2007 for the treatment of primary hypertension. It was developed as the first drug to directly inhibit renin, the enzyme that cleaves angiotensinogen to angiotensin I, beginning a chain of events that leads to vasoconstriction and high blood pressure.

Norvasc was launched by Pfizer in 1990. Mylan introduced the first generic version of the drug in 2007 after mounting a legal challenge to Pfizer's patent, and generic amlodipine is now widely available from multiple manufacturers.

Tekamlo will be sold in four dosage strength: 150 mg/5 mg tablets, 150 mg/10 mg tablets, 300 mg/5 mg tablets and 300 mg/10 mg tablets.

27th August 2010

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