The U.S. Food and Drug Administration (FDA) on Tuesday announced the approval of Tekturna (aliskiren) tablets for the treatment of high blood pressure.

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.

High blood pressure, or hypertension, affects an estimated 25 percent of Americans and causes increased risk of stroke, heart attack, kidney failure, heart failure and death.

Hypertension is rightly called "the silent killer" because it usually has no symptoms until it causes major damage to the body organs. "Today's approval adds a new safe and effective treatment option for people who need help to control their blood pressure," said Douglas C. Throckmorton, M.D., Deputy Director of FDA's Center for Drug Evaluation and Research.

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. When Tekturna was used in combination with hydrochlorothiazide, a diuretic, further reductions in blood pressure were achieved.

Side effects were usually mild and brief. The most common side effect experienced by patients taking Tekturna was diarrhea. Rarely, patients taking Tekturna developed an allergic reaction with swelling of the face, lips or tongue and difficulty breathing.

Tekturna and other drugs that act directly on the renin-angiotensin system should not be used during pregnancy because they can cause injury and even death to the developing fetus.

Tekturna is manufactured by Novartis Pharmaceuticals Corp., East Hanover, N.J.

Source: Xinhua