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FDA Green Lights New Blood Pressure Drug

March 6, 2007

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The U.S. Food and Drug Administration has approved 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.

The drug is manufactured by Novartis Phamaceuticals.

Tekturna 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 agency said the effectiveness of Tekturna in lowering blood pressure was 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. The FDA said 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.

Tekturna was evaluated for safety in more than 6,460 patients, including 1,740 who were treated longer than six months, and more than 1,250 for over one year.

Side effects were usually mild and brief. The most common side effect experienced by patients taking Tekturna was diarrhea. Diarrhea was reported by approximately 2 percent of patients on the higher of the two approved doses, compared with approximately 1 percent on placebo.

Rarely, patients taking Tekturna developed an allergic reaction with swelling of the face, lips or tongue and difficulty breathing, as has been seen with other drugs for high blood pressure that act directly on the renin-angiotensin system.

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.

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