The U.S. Food and Drug Administration (FDA) today announced the approval of Tekturna (aliskiren) tablets for the treatment of high blood pressure, or hypertension, which affects an estimated 25 percent of Americans and causes increased risk of stroke, heart attack, kidney failure, heart failure and death.
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.
"Hypertension is rightly called "the silent killer" because it usually has no symptoms until it causes major damage to the body organs," said Douglas C. Throckmorton, M.D., Deputy Director of FDA"s Center for Drug Evaluation and Research. "Today"s approval adds a new safe and effective treatment option for people who need help to control their blood pressure."
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, a diuretic, further reductions in blood pressure were achieved.