Swiss drugmaker Novartis has filed Rasilez, its potential new treatment for high blood pressure, with the US Food and Drug Administration. If approved, the renin inhibitor would offer the first new treatment approach in more that 10 years for people with the condition, the group said.
Rasilez’ (aliskiren) application is based on data from more than 6,000 people with high blood pressure, which showed that it induced significant blood pressure reductions that were sustained over 24 hours. This sustained effect offers a particularly important benefit, as it combats the blood pressure surges that can occur throughout the day and especially in the early morning, according to Novartis.
Commenting on the agent’s potential, James Shannon, Head of Development at Novartis Pharma, remarked: "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."
Not only have clinical trials shown the drug to be safe, with a “placebo-like tolerability” when used alone, but studies also revealed that it helped patients already taking ACE inhibitors, calcium channel blockers or a diuretic to lower their blood even further, helping them to reach their treatment targets, the firm said.
Rasilez has a unique mode of action in that it inhibits rennin, which activates the Renin System - the control center of blood pressure regulation. Said 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.”
High blood pressure is a massive problem in the western society; the American Heart Association estimates that it affects around 1 billion people across the globe. But current therapies are not doing enough to treat the problem, and a substantial portion of patients – as many as 70% - fail to reach blood pressure target levels.
In addition, Novartis points out that many existing treatments fail to provide sustained 24-hour control, particularly during the early morning hours, and so the potential for a new, effective therapy is substantial. Analysts estimate that Rasilez has potential to be a blockbuster product with sales in excess of $1 billion,