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European Commission Approval Granted for Blood Pressure Drug

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The pharmaceutical company Novartis in Basel, Switzerland says its drug Rasitrio has received approval from the European Commission (EC) for the treatment of hypertension or high blood pressure. The drug was designed for blood pressure patients who need multiple medications to treat their condition.

Rasitrio has the compound Rasilez, an inhibitor of the enzyme renin produced by the kidneys. Rasilez plays a role in the release of aldosterone, a hormone that helps control the body’s salt and water balance that can lead to constricting blood vessels. The drug also contains a calcium channel blocker amlodipine and diuretic hydrochlorothiazide that work with Rasilez.

Novartis says Rasilez binds to and inhibits renin, while the calcium channel blocker amlodipine lowers blood pressure by relaxing the blood vessel walls, and the diuretic hydrochlorothiazide increases the excretion of sodium chloride and water. All three medicines enable blood to flow more easily, thus lowering blood pressure.

The EC approved Rasitrio for patients with high blood pressure that are need a combination of the three components in the same dose. Novartis estimates that up to 85 percent of hypertension patients may need multiple medications to control their blood pressure, but regularly taking several different medications can be a challenge for many patients.

The approval of Rasitrio is based on phase 3 clinical trial data from nearly 1,200 high blood pressure patients. The study data show Rasitrio produced statistically significant blood pressure reductions compared to dual combinations of each of its individual components. Rasitrio’s effects were observed as early as one week after the start of therapy and was maintained over the entire 24-hour dose interval.

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