Speedel: US approval for SPP100 combined with diuretic to treat hypertension
Speedel Holding Ltd announced that the FDA approved a second product containing SPP100 (aliskiren) in the USA for the treatment of hypertension. The approval was announced by Novartis who is responsible for commercialisation of this first in class direct renin inhibitor.
Tekturna HCT® (aliskiren and hydrochlorothiazide) has been approved by the US Food and Drug Administration as a single-tablet combination of two high blood pressure medicines - Tekturna® (aliskiren), the first new type of high blood pressure medicine in more than a decade, and the diuretic hydrochlorothiazide (HCT). This is the first regulatory approval of a single-tablet combination therapy involving Tekturna®, known as Rasilez® outside the US, which has been shown to consistently lower blood pressure for 24 hours and beyond. HCT, sometimes called a "water pill", is one of the most commonly-used high blood pressure medicines.
The two medicines in this single-tablet combination work together in complementary ways to lower blood pressure, with clinical data showing that the combination of Tekturna and HCT offers greater blood pressure reductions than either component alone.
The US approval of Tekturna HCT was based on clinical trials involving more than 2,700 patients treated with Tekturna and HCT.
Other news from the department research and development
