Novartis has received a positive opinion recommending European Union approval of Rasilez (aliskiren) as the first new type of high blood pressure treatment in more than a decade.

The Committee for Medicinal Products for Human Use (CHMP), which reviews medicines for the European Commission, issued the positive opinion for Rasilez based on data from more than 7,800 patients in 44 clinical studies. The Commission generally follows the CHMP's recommendations and is expected to issue a decision within three months.

The clinical trial programme showed that Rasilez provided significant blood pressure reductions for 24 hours and beyond3. Furthermore, Rasilez provided added efficacy when used in combination with other commonly used blood pressure medications.

Studies estimate that nearly one billion people may have high blood pressure and that nearly 70% of patients with high blood pressure never reach healthy blood pressure levels. As a result, they live at risk of complications like heart attack, stroke, blindness and premature death, creating a strong need for new therapies like Rasilez.

"This important milestone for Rasilez comes just days after the US approval of Exforge as our new fixed combination therapy. Following the anticipated EU approval of Rasilez, our new antihypertensive medicines will be made available to patients in the US, Europe and elsewhere as quickly as possible. We have made significant progress in developing a broad and complementary portfolio of medicines to help physicians worldwide treat patients with high blood pressure," said Thomas Ebeling, CEO of Novartis Pharma.

Rasilez is the first in a new class of drugs called direct renin inhibitors. It acts by directly inhibiting renin, an enzyme that triggers a process leading to high blood pressure. The medication received its first approval in March 2007 from the US Food and Drug Administration under the trade name Tekturna.

"If approved, Rasilez will offer millions of Europeans an important new treatment option for high blood pressure," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "This positive opinion is highly encouraging since Rasilez has been shown to help a wide variety of people by providing long-lasting blood pressure control."

In clinical trials, the approved doses of Rasilez demonstrated a placebo-like tolerability profile4. Rasilez was developed in collaboration with Speedel.

Blood pressure measurements consist of two values: the first represents the pressure within blood vessels when the heart contracts, while the second represents the pressure when the heart is at rest between beats. Blood pressure is measured in millimeters of mercury (mmHg), with normal blood pressure levels between 120/80 mmHg and 140/90 mmHg.