FDA APPROVES NOVARTIS' TEKTURNA FOR HIGH BLOOD PRESSURE

The FDA announced it has approved Novartis' Tekturna tablets for the treatment of high blood pressure. Tekturna is the first hypertension drug approved by FDA that inhibits renin, a kidney enzyme associated with the regulation of blood pressure. Tekturna acts at the beginning of the blood pressure regulation process, while other available blood pressure drugs act at later stages.

The effectiveness of Tekturna (aliskiren) in lowering blood pressure has been demonstrated in six placebo-controlled, eight-week clinical trials that studied more than 2,000 patients with mild to moderate hypertension.

The effect was maintained for up to one year. Tekturna was effective across all demographic subgroups, but black patients tended to have smaller reductions in blood pressure than caucasians and Asians, as is generally true for drugs that affect the renin-angiotensin system, the FDA said.

Tekturna is approved as a monotherapy or in combination with other blood pressure medications, Novartis said. When the drug was used in combination with hydrochlorothiazide, a diuretic, further reductions in blood pressure were achieved.

The drug has not yet been approved in any other country, according to Novartis. The company developed the drug in collaboration with Speedel.