FDA Approves New Drug Treatment for High Blood Pressure

The U.S. Food and Drug Administration (FDA) this week announced the approval of Tekturna (aliskiren) tablets for the treatment of high blood pressure, which affects an estimated 25 percent of Americans. Tekturna, a new molecular entity (NME), is the first high blood pressure 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 high blood pressure medications act at later stages. The effectiveness of Tekturna in lowering blood pressure has been demonstrated in six placebo-controlled eight-week clinical trials, which 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 African American 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, a component of blood pressure regulation. When Tekturna was used in combination with hydrochlorothiazide, further reductions in blood pressure were achieved. Tekturna is manufactured by Novartis Pharmaceuticals Corp., East Hanover, N.J.