Tekturna HCT(R), a Single-tablet Combination of Tekturna(R)* and a Diuretic has receives US Approval for treatment of High Blood Pressure

Tekturna HCT® (aliskiren and hydrochlorothiazide) tablets 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 approved direct renin inhibitor, and the diuretic hydrochlorothiazide (HCTZ).

The two medicines in this single-tablet combination work together to lower blood pressure, with clinical data showing that the combination of Tekturna and HCTZ offers greater blood pressure reductions than either component alone.

Speedel a public biopharmaceutical company is a world leader in renin inhibition, a promising new approach with significant potential for treating cardiovascular diseases. The company’s lead compound SPP100 (Tekturna/Rasilez) a first-in-class direct renin inhibitor was in-licensed from Novartis in 1999 and licensed-back to Novartis Pharma in 2002 for further development and commercialization.

This is the first regulatory approval of a single-tablet combination therapy involving Tekturna, known as Rasilez® outside the US. HCT, sometimes called a "water pill", is one of the most commonly-used high blood pressure medicines. Tekturna HCT is approved for patients not controlled by either medicine alone but should not be used before other medications have been tried first.

High blood pressure is estimated to affect nearly one-in-three adults in the US and remains uncontrolled in nearly 70% of treated and untreated adults. Most patients require two or more medicines to reach their target blood pressures. Single-tablet combinations such as Tekturna HCT simplify high blood pressure management by reducing the number of pills people take daily.

The US approval of Tekturna HCT was based on clinical trials involving more than 2,700 patients treated with Tekturna and HCTZ.

In a study to evaluate rebound hypertension, when Tektuturna was withdrawn, blood pressure reductions were maintained for up to four days after the last dose, with blood pressure gradually returning toward baseline.

Tekturna is the only drug that works by targeting renin and decreasing the activity of the renin system, as measured by plasma renin activity (PRA). The reductions in PRA were not dose dependent and did not correlate with blood pressure reductions, and the clinical relevance of these reductions are unknown. By reducing the effects of renin, Tekturna helps blood vessels to widen so blood pressure is lowered. Diuretics work to lower blood pressure by ridding the body of unneeded water and salt, but are also known to increase PRA.