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Novartis blood pressure drug approved

Novartis has won marketing approval from the US Food and Drug Administration for Amturnide, a combined blood pressure drug

Novartis has won marketing approval from the US Food and Drug Administration (FDA) for Amturnide, a blood pressure drug that combines into one tablet the company's blockbuster Tekturna (aliskiren), which is the only approved direct renin inhibitor; the calcium channel blocker amlodipine; and the diuretic hydrochlorothiazide. 

Specifically, the FDA approved the once-daily drug for patients whose blood pressure is not adequately controlled with any two of its individual components. The drug is not indicated as initial therapy for high blood pressure.

The tablet is the third triple-drug combination therapy in a single pill to be approved by the FDA for high blood pressure. Novartis noted that up to 85 per cent of patients with high blood pressure may need multiple medicines for the condition.  

The data Novartis submitted to the FDA showed that Amturnide provided significantly greater reductions in blood pressure compared to all dual combinations of the component drugs. The study enrolled 1,181 patients with moderately or severely elevated blood pressure and found that both patient populations achieved greater systolic and diastolic blood pressure reductions with Amturnide compared to dual combination treatment of aliskiren/amlodipine, aliskiren/ hydrochlorothiazide or amlodipine/ hydrochlorothiazide.   

Amturnide is being launched in five strengths: aliskiren 150mg / amlodipine 5mg/ hydrochlorothiazide 12.5mg tablets; 300mg/5mg/12.5mg tablets; 300mg/5mg/25mg tablets; 300mg/10mg/12.5mg tablets; and 300mg/10mg/25mg tablets.

Tekturna had sales of $113m during the third quarter of 2010, up 42 per cent over the same quarter a year earlier. Novartis launched the drug in the US in 2007 as a more effective follow-up to its blood pressure drug Diovan (valsartan), which is due to go off-patent in 2012.

23rd December 2010

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