New Drug Application for high blood pressure drug Rasilez accepted for review by FDA

By E. Janene Geiss

Philadelphia, April 20 - Novartis Pharmaceuticals Corp. said Thursday the Food and Drug Administration has 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, according to a company news release.

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, officials said.

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," James Shannon, head of development at Novartis Pharma AG, said in the release.

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, officials said.

In clinical studies, Rasilez was well-tolerated when used with the most common cardiovascular and diabetic medications.

Rasilez 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.

Novartis Pharmaceuticals, based in East Hanover, N.J., researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. It is an affiliate of Novartis AG, a Basel, Switzerland, pharmaceutical and health care products company.

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