Rasilez (aliskiren), the first new type of high blood pressure medicine in more than a decade, has been approved for use in Japan. Rasilez directly inhibits renin, an enzyme that triggers a process leading to high blood pressure and organ damage. The Ministry of Health, Labour and Welfare (MHLW) in Japan approved Rasilez for the treatment of high blood pressure alone or in combination with other high blood pressure medicines.
High blood pressure is the leading risk factor for cardiovascular disease, the number one cause of death worldwide. In Japan an estimated 40 million people, nearly a third of the population, are affected by high blood pressure with the majority of patients not reaching their blood pressure treatment goal.
"In Japan, nearly 70 per cent of patients are not reaching their blood pressure goal, demonstrating a strong need for therapies with a new mechanism of action," said professor Toshiro Fujita, chief of the Department of Nephrology and Endocrinology, University of Tokyo. "It is expected that Rasilez's unique mechanism of action will provide significant blood pressure reductions that last for 24 hours."
It is estimated that nearly one billion people globally have high blood pressure and many of these remain either untreated or treated but not reaching their target. Patients are therefore at risk of complications including heart attack, stroke, kidney failure, blindness and death, creating an unmet need for new high blood pressure therapies.
Rasilez, known as Tekturna in the US, works by directly inhibiting renin to reduce the effects caused by an over-active renin system. By inhibiting renin at the point of activation, Rasilez provides significant blood pressure reductions alone or in combination with other antihypertensives.
The potential long-term benefits of Rasilez are currently being investigated further in the landmark aspire higher programme, the largest ongoing cardio-renal outcomes programme worldwide, involving more than 35,000 patients in 14 trials.
"We are very excited about the approval in Japan, which provides Japanese patients access to this innovative high blood pressure treatment that directly targets renin," said Trevor Mundel, Global head of Development at Novartis Pharma AG. "Novartis is committed to supporting the research and development of effective and innovative treatments for patients suffering high blood pressure."
Rasilez is approved in over 70 countries. Tekturna was approved in the US in March 2007 and in the European Union in August 2007 under the trade name Rasilez. Tekturna HCT, the first single-pill combination involving Tekturna, was approved in the US in January 2008. The single-pill combination Rasilez HCT was approved by the European Commission in January 2009.
Novartis is focused on improving the lives of the hundreds of thousands of people with cardiovascular and metabolic diseases. As a global leader in cardiovascular and metabolic health for nearly 50 years, Novartis provides innovative therapies and support programs to treat high blood pressure and diabetes - both major public health issues. The portfolio includes the world's most-prescribed angiotensin receptor blocker, the first and only approved direct renin inhibitor, a single pill combining two leading high blood pressure medicines, and a DPP-4 inhibitor.