The FDA has approved Novartis’ Valturna (aliskiren and valsartan) tablets, a medicine targeting two key points within the renin system, also known as the renin angiotensin aldosterone system (RAAS), a regulator of blood pressure. This is the first approval for Valturna, which is indicated for the treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker (ARB) monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

“This unique combination brings together the powerful blood pressure lowering effects of valsartan and aliskiren,” said Joe Jimenez, chief executive officer of the Novartis Pharmaceuticals Division. “It offers an important additional treatment 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.”

Valturna combines valsartan, the active ingredient in high blood pressure drug Diovan, and aliskiren, the active ingredient in Tekturna, a direct renin inhibitor (DRI). This approval was based on an eight-week randomized, double-blind, placebo-controlled trial in approximately 1,800 patients, which studied aliskiren 150 mg and 300 mg and valsartan 160 mg and 320 mg alone and in combination. Blood pressure reductions with the aliskiren/valsartan combination were significantly greater than with the monotherapies or placebo at the primary endpoint.

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