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New 2-in-1 Valturna outperforms Diovan

Published on 01/10/09 at 11:11am

Novartis has gained US approval for a combination of its blockbuster blood pressure drug Diovan and its follow-up product Tekturna/Rasilez.

Valturna is the first medicine to target two key points within the renin system, an important regulator of blood pressure, and Novartis says trial data shows it is more effective than either Diovan or Tekturna/Rasilez alone.

Diovan (valsartan) earned $5.7 billion in annual sales in 2008, and is the company 's biggest selling brand, but faces generic competition in the US from 2012.

Novartis launched Tekturna/Rasilez (aliskeren) in the US and Europe in 2007, but the drug has been disappointing in its uptake so far. Tekturna/Rasilez sales reached just $144 million in 2008, with generics and doctors being unconvinced of its additional benefits contributing factors to its underwhelming performance.

But sales of the drug look set to at least double in 2009, and Novartis hope that trial data suggesting the new combination is more effective than either drug alone will persuade doctors to prescribe it.

An eight week placebo-controlled trial in around 1,800 patients looked at the drugs in combination and alone, and found blood pressure reductions with the aliskiren/valsartan combination were significantly greater than with the monotherapies or placebo at the 8-week primary endpoint.

Mean systolic and diastolic blood pressure reductions from baseline were 17.2/12.2 mmHg for aliskiren 300 mg/valsartan 320 mg, compared with 12.8/9.7 mmHg for valsartan 320 mg, 13.0/9.0 mmHg for aliskiren 300 mg, and 4.6/4.1 mmHg for placebo (p<0.05 for aliskiren/valsartan vs monotherapies or placebo).

Joe Jimenez, chief executive of Novartis pharma division, said the new combination was an important new option for physicians and hypertension patients, many of whom are not at their blood pressure goal.

"Valturna builds upon our strong cardiovascular franchise and is consistent with our long-term commitment to developing effective and innovative therapies. It further strengthens our growing portfolio of single-pill combinations to treat high blood pressure, " Jimenez said.

"When it comes to diagnosing and treating high blood pressure, there is a real need for innovative therapies that help patients get to a healthier blood pressure range, " said John Flack, M.D., Valturna investigator, and Chairman of the Department of Internal Medicine, Wayne State University, Detroit.

Heart and kidney protection

The heart and kidney protection potential of Rasilez/Tekturna, in addition to its blood pressure lowering ability, is currently being investigated further in theASPIRE HIGHER programme, the largest ongoing cardio-renal outcomes programme worldwide involving more than 35,000 patients in 14 trials.

Tekturna HCT, the first single-pill combination involving Tekturna, was approved in the US in January 2008 for second-line treatment of high blood pressure, and more recently for first-line use. The single-pill combination Rasilez HCT was approved in the European Union in January 2009. Other single-pill combinations with Rasilez are currently in development including a single pill combination with amlodipine.

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