US regulators have given the green light to another hypertensive combination from Novartis, this time a treatment containing the Swiss major’s Tekturna/Rasilez and Diovan.
The US Food and Drug Administration has approved Valturna, a single-pill combination of Tekturna (aliskiren) and Diovan (valsartan). The combo is indicated for the treatment of high blood pressure in patients not adequately controlled on Tekturna, the only approved direct renin inhibitor, or angiotensin receptor blocker (ARB) monotherapy, eg Diovan, and as initial therapy in patients “likely to need multiple drugs to achieve their blood pressure goals”, Novartis noted.
The Basel-based group said that Valturna is the first medicine to target “two key points within the renin system”, an important regulator of blood pressure. The FDA approval is based on an eight-week trial in approximately 1,800 patients which studied aliskiren 150mg and 300mg and valsartan 160mg and 320mg alone and in combination. The data demonstrates that Valturna significantly lowered hypertension, compared with either of the monotherapies or placebo.
Novartis cited research which suggests that up to 85% of patients with high blood pressure may need multiple medications to help control their problem, “underscoring the need for effective combination treatments”. This was the theme taken up by head of pharma, Joe Jimenez, who said that Valturna offers an important additional treatment option for hypertension patients, “many of whom are not at their blood pressure goal”.
He added that the approval “further strengthens our growing portfolio of single-pill combinations to treat high blood pressure.” Tekturna HCT, which combines aliskiren with the diuretic hydrochlorothiazide, was approved in the USA for second-line treatment of high blood pressure at the beginning of 2008 and was given the thumbs-up for first-line use in July. Rasilez HCT was approved in the European Union in January 2009. A single-pill combination of aliskiren with Pfizer’s now off-patent Norvasc (amlodipine) is currently under development.
