Novartis has announced that Rasilez HCT, a single-pill combination of two high blood pressure medicines – first-in-class direct renin inhibitor Rasilez and the diuretic hydrochlorothiazide – has received approved from Swissmedic as a new treatment for high blood pressure.
The first new type of blood pressure medicine in over a decade Rasilez, known as Tekturna in the US, provides effective blood pressure lowering that lasts beyond 24 hours. HCT, sometimes called a 'water pill', is said to be one of the most commonly used diuretics in the treatment of high blood pressure.
According to the company, Rasilez HCT is twice as effective at reducing blood pressure compared to HCT alone. The Swiss approval of Rasilez HCT for patients not controlled by either medicine alone follows the US approval of Tekturna HCT earlier 2008. The submission was based on clinical trials involving more than 2,700 patients.
Trevor Mundel, head of global development functions at Novartis Pharma, said: "Having received the US approval of Tekturna HCT earlier in 2008, we are pleased to now have regulatory approval of Rasilez HCT in Switzerland.
"This regulatory decision also supports expanded regulatory submissions in 100 countries worldwide. We are expecting a regulatory decision from the European health authorities for Rasilez HCT in the first quarter of 2009."