Rasitrio acts by targeting renin for optimal control of the renin angiotensin aldosterone system (RAAS), which is a key regulator of high blood pressure.
The approval is based on Phase III data which demonstrated the efficacy of the treatment.
The study comprising over 1,181 high blood pressure patients showed that Rasitrio reduced the blood pressure significantly as compared to dual combinations of each of its individual components, including aliskiren/amlodipine 300 mg/10 mg, aliskiren/HCTZ 300 mg/25 mg and amlodipine/HCTZ 10 mg/25 mg.