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Novartis submits next generation blood pressure drug

Published on 29/09/06 at 02:48pm

Next generation hypertension drug Rasilez has been submitted for EU approval.

If approved, Rasilez will be the first ever renin inhibitor, a promising new class of drugs and the first new approach to treating high blood pressure in more than a decade.

The drug works by directly inhibiting renin, the key enzyme at the top of the Renin Angiotensin System (RAS), one of the most important regulators of blood pressure.

Analysts have already predicted peak sales of around $2.5 billion for the drug.

It has been estimated that high blood pressure, along with its consequences, is the world's number one killer. The American Heart Association said it affects one in four adults globally, around one billion people.  

Rasilez has been developed in collaboration with biotech company Speedel and acts by suppressing the renin systems point of activation.

The drug's apparent ability to produce 24-hour blood pressure control particularly in the early morning when blood pressure can surge in patients could be another key claim over existing treatments.

In addition to an effective monotherapy, the makers say Rasilez further reduces blood pressure when given alongside existing anti-hypertension therapies, including ACE inhibitors, calcium channel blockers (CCBs) or the diuretic hydrochlorothiazide (HCTZ).

Prof Roland Schmieder from the department of nephrology and hypertension at Germany's University of Erlangen-Nuremberg, said: "Physicians and patients need new therapeutic approaches for controlling blood pressure and its associated complications. We have been hoping for a direct renin inhibitor for a long time.

He added: "Data on Rasilez shows that directly inhibiting renin can provide the control our patients need and might provide other long-term benefits."

A number of other companies are investigating the potential of renin inhibitors. This includes an alliance between Switzerland's Actelion and the US' Merck, but their first compound in the class only entered clinical development in July this year.

GSK has teamed up with US biotech Vitae on a similar alliance, forged just over a year ago.

According to analysts, the hypertension market generated $25 billion in 2004. Revenues are forecast to grow to nearly $30 billion per year by 2010.


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