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FDA Approvals: Tekturna

Authors: News Author: Michael O'Riordan CME Author: Yael WaknineFaculty and Disclosures


from Heart wire — a professional news service of WebMD

March 22, 2007 — 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).

One expert, however, remains unsure where aliskiren will fit into the antihypertensive arsenal.

"Clearly, a new drug with a unique mechanism of action is a welcome addition," Franz Messerli, MD, from St. Luke's-Roosevelt Hospital in New York, told heartwire . "However, there are several questions coming to mind. Is there a need for triple blockade of the renin angiotensin system, and if so, what is the risk/benefit ratio? If the prorenin story plays out — and that's a big if — conceivably aliskiren will have distinct advantages in the diabetic patient. From a purely antihypertensive point of view, I cannot conceive that a drug that has a very similar shallow dose-response curve as the angiotensin-receptor inhibitors but seems to have more adverse effects will confer a distinct advantage."

Where aliskiren might be advantageous, said Dr. Messerli, is in patients who cannot take angiotensin-converting enzyme (ACE) inhibitors because of cough or angioedema or those who need a double blockade of the renin angiotensin system, such as diabetic patients with albuminuria. He added that while there seem to be many unanswered questions, "this is not unusual when a new compound is introduced, because our vision of efficacy and safety is still narrow because of the lack of data."

In December 2006, the FDA extended by 3 months its review of aliskiren following the voluntary submission of more data by Novartis. Preclinical work in rats showed some irritation of the colonic mucosa with the drug, so a decision was made to do a further study in 30 healthy volunteers. Results of this showed no changes in the mucosal lining of the colon, Novartis said.

Financial analysts have previously suggested that aliskiren may generate sales of at least $1 billion a year.

The complete contents of Heart wire , a professional news service of WebMD, can be found at, a Web site for cardiovascular healthcare professionals.

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