FDA approves Novartis' blood pressure treatment

EAST HANOVER, N.J. A drug maker has received approval from the Food and Drug Administration for a medication designed to regulate blood pressure.

Novartis received approval for Valturna (aliskiren and valsartan) tablets, the first and only medicine to target two key points within the renin system, an important 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 monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

The single-pill combination Valturna targets the RAAS in two ways. The valsartan component blocks, at the receptor level, the action of angiotensin II, an important end product of the RAAS that causes blood vessels to tighten and narrow. The aliskiren component reduces angiotensin II levels by directly inhibiting renin, an enzyme produced by the kidneys that starts a process which leads to formation of angiotensin II. An overactive RAAS is an important contributor to high blood pressure in many patients. By targeting two key points within the RAAS, Valturna helps blood vessels relax and widen so blood pressure is lowered.

"This unique combination brings together the powerful blood pressure lowering effects of valsartan and aliskiren," said Joe Jimenez, CEO 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."