FDA Approves Novartis's Valturna to Lower Hypertension

A new blood-pressure treatment has come on the market that is of potential interest to hypertension patients whose blood pressure is not being adequately controlled with monotherapy.

Last month, the US Food and Drug Administration (FDA) approved Novartis’ Valturna (aliskiren and valsartan), which combines in a single pill valsartan, the active ingredient in Diovan — the top-selling branded high blood pressure medicine — and aliskiren, the active ingredient in Tekturna — the only approved direct renin inhibitor (DRI).

Valturna is the first and only medicine to target two key points within the renin system, an important regulator of blood pressure. It is suitable for patients whose high blood pressure has not been adequately controlled on aliskiren alone, or by an angiotensin receptor blocker, such as Diovan, alone. It could also be considered as an initial treatment for patients who are likely to need multiple drugs to achieve their blood pressure goals.

The US Food and Drug Administration (FDA) has approved Valturna® (aliskiren and valsartan) tablets, the first and only medicine to target two key points within the renin system, also known as the renin angiotensin aldosterone system (RAAS), 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 (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, 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."

The FDA has approved Valturna (aliskiren and valsartan tablets, from Novartis), a combination agent containing a direct renin inhibitor and an angiotensin receptor blocker, 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.