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Aliskiren NDA Accepted for Review by FDA

EAST HANOVER, N.J., April 20 /PRNewswire/ -- Novartis Pharmaceuticals Corporation announced today that the US Food and Drug Administration (FDA) accepted its application for Rasilez (aliskiren) as a treatment for high blood pressure. As a renin inhibitor, Rasilez would represent the first new treatment approach for people with high blood pressure in more than a decade.

The Rasilez application includes data from more than 6,000 people with high blood pressure. Data from the Rasilez application showed that when used alone Rasilez produced significant blood pressure reductions sustained over 24 hours. Sustained blood pressure reductions throughout the day, especially in the early morning when blood pressure surges occur, is a potentially important benefit.

"The sustained 24-hour blood pressure control achieved with once-daily Rasilez is good news for people with high blood pressure," said James Shannon, MD, Head of Development, Novartis Pharma AG. "This innovative medicine has the potential to redefine future treatment standards, and studies are now underway to evaluate potential long-term benefits beyond blood pressure control."

Throughout the clinical program, Rasilez showed placebo-like tolerability when used alone. When used with ACE inhibitors, calcium channel blockers, or a diuretic, Rasilez delivered additional blood pressure reductions, helping people already on therapy to reach their blood pressure goals. In clinical studies, Rasilez was well tolerated when used with the most common cardiovascular and diabetic medications.

"We continue to need new therapeutic approaches to control blood pressure," said Michael Weber, MD, Professor of Medicine at SUNY Downstate Medical Center in New York. "Renin inhibition has long been considered a logical and highly desired treatment approach. The Rasilez data show that inhibiting renin directly is effective in reducing blood pressure, and in this case, over 24 hours."

Renin inhibition: a unique mechanism of action
If approved Rasilez would be a first-of-its-kind treatment in the long search for effective oral renin inhibition. It acts within the Renin System, which is central to blood pressure regulation. By suppressing the system's point of activation -- renin -- Rasilez decreases the activity of the Renin System, as measured by plasma renin activity (PRA).

In the clinical trial program, Rasilez has consistently shown tolerability similar to placebo up to 300 mg (within the expected therapeutic dose range). The most commonly reported adverse events for Rasilez include diarrhea, headache and nasopharyngitis (inflammation of the nose). All drugs that act directly on the renin angiotensin system carry a warning that they should not be used in pregnant women due to the risk of injury and even death to the fetus.

About high blood pressure
High blood pressure -- and its consequences -- is the world's number 1 killer and is estimated by the American Heart Association to affect one in four adults -- around 1 billion people globally. Despite extensive use of current therapies, 70% of all people with high blood pressure do not reach target blood pressure levels. Many people require 3 or more medicines to control their blood pressure. Meanwhile, many existing treatments fail to provide sustained 24-hour blood pressure control, particularly during the early morning hours.

Source: Novartis

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