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news.The FDA has accepted Novartis' application for Rasilez 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.
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The Rasilez application includes data from more than 6,000 people with high blood pressure. In these studies 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.
According to Novartis, 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. Rasilez was also well tolerated when used with the most common cardiovascular and diabetic medications.
“We continue to need new therapeutic approaches to control blood pressure,” said Dr Michael Weber, 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.”