The CHMP has adopted a positive opinion for Novartis’ Rasitrio, recommended as replacement therapy for patients with high blood pressure.
The single-pill treatment combines calcium channel blocker amlodipine with the diuretic hydrochlorothiazide (HCT) and Rasilez, the only approved direct renin inhibitor in the world.
Professor Roland E. Schmieder at the University Hospital of the University Erlangen-Nuremberg, Germany, commented that the drug will provide patients with a “comprehensive and convenient high blood pressure treatment in one pill”.
The CHMP positive opinion of Rasitrio is based on a Phase III clinical trial involving more than 1,181 patients with high blood pressure. Data showed that Rasitrio significantly reduced blood pressure compared to dual combinations of each of its individual components.
David Epstein, Division Head of Novartis Pharmaceuticals, said: “This positive CHMP opinion is an important step towards approval and making this new triple combination therapy available for patients whose blood pressure is not under control and who may require multiple medications.”
Approximately 1 billion people have high blood pressure worldwide, with many remaining uncontrolled despite treatment, with up to 85% of patients requiring multiple medications to help control their blood pressure.
High blood pressure can cause damage to the heart, brain and kidneys and is also linked with other conditions such as diabetes.