Swiss drug major Novartis said this morning it has filed its new blood pressure drug Rasilez with the European Medicines Agency, bringing the agent one step closer to being the first in a new class of agents, known as renin inhibitors, to hit the market in over a decade.

Rasilez (aliskiren) works by activating the renin system - the control centre of blood pressure regulation. As Michael Weber, Professor of Medicine at SUNY Downstate Medical Center in New York, explained when the agent was filed in the USA earlier this year: “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.”

The European submission includes data from more than 7,800 patients with high blood pressure taking Rasilez in 44 clinical trials. Results show that the drug “produces sustained double-digit reductions in blood pressure, reaches its maximal lowering effect within four weeks, and has placebo-like safety and tolerability within the expected therapeutic dose range,” the company said.

But findings also revealed that Rasilez is able to further reduce blood pressure when given in combination with many commonly used anti-hyptertensives, such as angiotensin converting enzyme inhibitors or calcium channel blockers, adding to its abilities as a monotherapy.

High blood pressure is a big problem in 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.

And further bolstering its already promising competitive profile was data released earlier this month, which showed that Rasilez is able to control blood pressure in patients without the risk that symptoms will get worse after therapy stops, as often happens with other antihypertensives.

Novartis is hoping that Rasilez, which was originally licensed from Swiss biotechnology group Speedel, will be a star player in its blood pressure portfolio. This is currently being driven by Diovan (valsartan), which retained its position at the top of Novartis’ sales league in the first six months of 2006, racking up nearly $1.9 billion, but is due to lose its patent armour in 2012.