The FDA has approved Valturna (aliskiren and valsartan) tablets, the first drug to target two key points within the renin system, also known as the renin angiotensin aldosterone system, a regulator of blood pressure.
Valturna 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, according to the East Hanover, N.J.-based Novartis.
Valturna combines valsartan, the active ingredient in Diovan, a branded high blood pressure medicine, and aliskiren, the active ingredient in Tekturna, a direct renin inhibitor, the company said.
The approval was primarily based on a pivotal eight-week randomized, double-blind, placebo-controlled clinical 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. The initial doses of aliskiren and valsartan were 150 mg and 160 mg, respectively, and were increased at four weeks to 300 mg and 320 mg, respectively.
According to the company, blood pressure reductions with the aliskiren/valsartan combination were significantly greater than with the monotherapies or placebo at the eight-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 mmHg for aliskiren 300 mg, and 4.6/4.1 mmHg for placebo.