Rasilez (aliskiren), a new medicine that would represent the first new treatment approval for people with high blood pressure in more than a decade, has been submitted for European Union approval.
The submission, which was accepted by the European Medicines Agency (EMEA), includes data from more than 7,800 patients with high blood pressure taking Rasilez in 44 clinical trials. These results show Rasilez 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, a Novartis release stated.
In addition to being effective by itself as a monotherapy, Rasilez further reduces blood pressure when co-administered with many common anti-hypertension therapies, including angiotensin converting enzyme inhibitors (ACE inhibitors), calcium channel blockers (CCBs) or the diuretic hydrochlorothiazide (HCTZ).
High blood pressure - and its consequences - is the world's No. 1 killer and is estimated by the American Heart Association to affect one in four adults - around one billion people globally. Despite extensive use of current therapies, about 70 per cent of all people with high blood pressure do not reach their target blood pressure levels. Many patients require three or more medicines to control their blood pressure. Meanwhile, many existing treatments fail to provide sustained 24-hour blood pressure control, particularly during the early morning hours.
Rasilez, which was developed in collaboration with Speedel AG, is a first-of-its-kind treatment resulting from the long search for effective renin inhibition through an oral medicine. It acts within the renin system, which is central to blood pressure regulation. By suppressing the renin system's point of activation - renin - Rasilez decreases the activity of this system, as measured by plasma renin activity (PRA).
"Physicians and patients need new therapeutic approaches for controlling blood pressure and its associated complications. We've been hoping for a direct renin inhibitor for long time," said Professor Roland Schmieder, Department of Nephrology and Hypertension at the University of Erlangen-Nürnberg in Germany. "Data on aliskiren show that directly inhibiting renin can provide the control our patients need and might provide other long-term benefits."
The most recent clinical data, which was presented in September, highlighted the power of Rasilez to maintain its 24-hour blood pressure lowering over one year of therapy and to continue its lowering effects for up to four weeks after the medicine was stopped.
Throughout the clinical programme, Rasilez has consistently shown tolerability comparable to placebo at doses up to 300 mg daily. Rasilez has also been well-tolerated when used alone or with other common cardiovascular and anti-diabetic medicines.
"For more than 40 years, medical researchers have focused on controlling over-activation of the renin system," said James Shannon, MD, Global Head of Development at Novartis. "As a direct renin inhibitor, Rasilez has the potential to redefine how high blood pressure is treated. We intend to conduct a large clinical program involving more than 40,000 patients to evaluate the potential long-term benefits of Rasilez beyond blood pressure control."
In April 2006 the US Food and Drug Administration (FDA) accepted aliskiren for regulatory review. Submissions in other markets are planned.