FDA Approves Novartis's Tekturna to Lower Hypertension

The FDA today approved a new drug called Tekturna to treat hypertension (high blood pressure). Tekturna is the first FDA-approved drug in a new class of high blood pressure drugs called renin inhibitors.

The kidneys make renin, an enzyme, to help regulate blood pressure.

Renin can raise blood pressure. Tekturna, taken once daily by mouth, blocks that process.

"Hypertension is rightly called 'the silent killer' because it usually has no symptoms until it causes major damage to the body organs," says the FDA's Douglas Throckmorton, MD, in an FDA news release.

Results from a new study have shown patients taking two Novartis cardiovascular medicines - the recently US-approved drug Tekturna® (aliskiren) and the leading therapy Diovan® (valsartan) - experienced greater reductions in blood pressure levels than those using either agent alone.

The study also found more patients receiving both Tekturna, which received US approval in March and represents the first type of new high blood pressure medicine in a decade, and Diovan reached their treatment goal compared to either drug alone

The US Food and Drug Administration (FDA) has approved Tekturna HCT® (aliskiren and hydrochlorothiazide) tablets as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. Tekturna HCT is a single-pill combination of Tekturna® (aliskiren), the first and only approved direct renin inhibitor, and the diuretic hydrochlorothiazide (HCTZ), one of the most commonly used high blood pressure medications.
The FDA approval of Tekturna HCT as initial therapy was based on clinical trial data involving more than 2,700 patients, which showed that treatment with the combination of Tekturna and HCTZ offered greater blood pressure reductions than either drug alone.

The Food and Drug Administration (FDA) has approved the blood-pressure drug aliskiren ( Tekturna, Novartis), the first new antihypertensive medication to be approved in more than 10 years.

The drug is the first in a new class of agents known as oral renin inhibitors and is approved for the treatment of high blood pressure as monotherapy or in combination with other antihypertensive medications. The drug is expected to be available in pharmacies in March in 150-mg and 300-mg doses.

A once-daily oral tablet, aliskiren blocks the action of renin at the top of the renin-angiotensin-system cascade. A pooled data analysis of antihypertensive treatment with the drug in more than 8000 patients, presented by Matthew R. Weir, MD, from the University of Maryland School of Medicine in Baltimore, at the World Congress of Cardiology in Barcelona in September 2006 and previously reported by heart wire , suggested that it reduces blood pressure effectively regardless of age or sex, is well tolerated, and appears to be additive to most other antihypertensive agents, with the exception of angiotensin-receptor blockers (ARBs).