Tekturna combo gets US OK

The Swiss pharma has combined its recently approved hypertension drug with hydrochlorothiazide (HCT) to create a single tablet treatment that has been shown to be more effective than using either component alone.

Tekturna (known as Rasilez outside the US) has been touted by Novartis as the first truly innovative blood pressure medication in over a decade, though there have been questions as to the safety and efficacy of this new class of rennin inhibitors.

Novartis, however, stands by its claims, and will be hoping that this first Tekturna combination product will further widen the appeal and market for the treatment.

The single tablet formulation combines HCT, one of the most commonly used blood pressure medications, with Tekturna, shown to lower blood pressure for 24 hours or more.

With many blood pressure patients requiring two or more medicines to treat their condition, the company sees the advantage of its combo treatment in reducing the number of tablets patients have to take and simplifying treatment.

The 24-hour-plus formulation is also seen as a bonus as many hypertension medicines do not work round the clock, missing the trouble spot in the early morning when blood pressure can surge.

Tekturna, according to Novartis, can last beyond 24 hours, and has been shown to maintain reduced blood pressure for up to four days after the last dose.

The drug, developed in collaboration with US firm Speedel, works by targeting renin, the key enzyme at the top of the Renin Angiotensin System (RAS), one of the key regulators of blood pressure.

The drug decreases the activity of the renin system and helps widen blood vessels to reduce blood pressure.

Diuretics work to lower blood pressure by clearing unneeded water and salt out of the body, but also increase plasma rennin activity.

The long-tem effects of Tekturna and direct rennin inhibition are being studied by Novartis in an extended study known as ASPIRE HIGHER, focusing on patients with cardiovascular or kidney disease.

Tekturna was approved as a monotherapy in the US in March 2007, followed three months later by EU approval under the brand name Rasilez.

Within days of the EU approval, Novartis unveiled plans for a major expansion to production facilities in Switzerland to cater for the anticipated demand for its hypertension medicines.

CHF300m ($272m) went towards the expansion at the Schweizerhalle plant near Basel, to provide adequate capacity for Tekturna but also Novartis' top-selling hypertension med Diovan (valsartan), production capacity for which will increase by 60 tons a year following the expansion.

Given the additional Tekturna indications and further combination treatments Novartis is working on for the first-in-class med, the capacity expansion reflects the significant role the company anticipates the drug playing in its portfolio.