FDA has approved Valturna (aliskiren and valsartan) tablets, which the drug’s maker, Novartis, of East Hanover, N.J., said is the first and only product to target two key points in the renin angiotensin aldosterone system (RAAS).
The single-pill combination is indicated for the treatment of hypertension in patients not adequately controlled on aliskiren (a direct renin inhibitor) or angiotensin receptor blocker monotherapy, and as initial therapy for patients likely to require multiple drugs to achieve their BP goals.
“When it comes to diagnosing and treating high blood pressure, there is a real need for innovative therapies that help patients get to a healthier blood pressure range,” said Valturna investigator John Flack, MD, Chairman of the Department of Internal Medicine at Wayne State University in Detroit. “Now for the first time, we have a treatment option in one pill that targets two key points of the RAAS, which may be overactive in many hypertensive patients.”
The approval was primarily based on a pivotal eight-week randomized, double-blind, placebo-controlled clinical trial in about 1,800 patients. Researchers studied aliskiren 150 mg and 300 mg and valsartan 160 mg and 320 mg alone and in combination. BP reductions with the aliskiren/valsartan combination were significantly greater than with either monotherapy or placebo at eight weeks.