FDA Approves Novartis’ Valturna

The FDA has Novartis’ approved Valturna (aliskiren and valsartan) tablets, a medicine to target two key points within the renin system, also known as the renin angiotensin aldosterone system (RAAS).

The approval for Valturna 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.

Valturna combines in a single pill valsartan, the active ingredient in Diovan and aliskiren, the active ingredient in Tekturna, direct renin inhibitor (DRI). Valturna offers significantly greater blood pressure reduction than either valsartan or aliskiren alone.

Reportedly, the approval was based on a pivotal eight-week randomised, double-blind, placebo-controlled clinical trial in approximately 1,800 patients, which studied aliskiren 150mg and 300mg and valsartan 160mg and 320mg alone and in combination.

The initial doses of aliskiren and valsartan were 150mg and 160mg, and were increased at four weeks to 300mg and 320mg, respectively. Blood pressure reductions with the aliskiren/valsartan combination were significantly greater than with the monotherapies or placebo at the eight-week primary endpoint.

However, mean systolic and diastolic blood pressure reductions from baseline were 17.2/12.2mmHg for aliskiren 300mg/valsartan 320mg, compared with 12.8/9.7mmHg for valsartan 320mg, 13.0/9.0mmHg for aliskiren 300mg, and 4.6/4.1mmHg for placebo.

The study result showed that the single-pill combination Valturna targets the RAAS in two ways. The valsartan component blocks, at the receptor level, the action of angiotensin II. Aliskiren component reduces angiotensin II levels by directly inhibiting renin.

Research suggests that up to 85% of hypertensive patients may need multiple medications to help control their blood pressure, underscoring the need for effective combination treatments.

Joe Jimenez, CEO of Pharmaceuticals Division at Novartis, said: “This combination brings together the powerful blood pressure lowering effects of valsartan and aliskiren. 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.”