Rasilez (aliskiren), a first-in-class direct renin inhibitor, has received regulatory approval in China for the treatment of high blood pressure alone or in combination with other high blood pressure medicines. Rasilez blocks the activity of renin, an enzyme that triggers a process that may lead to high blood pressure.
"We are pleased that our continued investment in China enables us to bring treatment options to patients that address the needs of this growing market," said David Epstein, Division head of Novartis Pharmaceuticals. "By adapting our development timelines for Rasilez we have been able to provide patients in China with timely access to this novel therapy for high blood pressure."
High blood pressure is the leading risk factor for cardiovascular disease, the number one cause of death worldwide. In China, an estimated 153 million adults are affected by high blood pressure, with the majority of patients not reaching their optimal treatment goal. The country's leading preventable cause of death, high blood pressure leads to more than one million premature deaths and over two million total deaths in China each year.
"Modifications in lifestyle and diet have led to high blood pressure becoming a significant and growing problem in China," said Yong Huo, president-elect Chinese Society of Cardiology, Department of Cardiology, Peking University First Hospital."Because the disease has no apparent symptoms, awareness as well as treatment and control of the condition are very low. As a result, there is a clear need for innovative high blood pressure treatments in China to enable more patients to successfully manage their condition."
It is estimated that over one billion people globally have high blood pressure, and many of these remain either untreated or treated but not reaching their target. High blood pressure causes damage to the vital organs of the body including the heart, brain and kidneys. However, if high blood pressure is properly controlled, the incidence of stroke and heart failure can be reduced by almost half, and heart attacks by one quarter.
Rasilez, known as Tekturna in the US, works by directly inhibiting the activity of renin, an enzyme produced by the kidneys that starts a process in the renin-angiotensin-aldosterone system which narrows blood vessels, and may lead to high blood pressure. By inhibiting renin at the point of activation, Rasilez provides significant blood pressure reductions alone or in combination with other antihypertensives.
Rasilez/Tekturna is approved in over 80 countries. Tekturna was approved in the US in March 2007 and in the European Union in August 2007 under the trade name Rasilez. In July 2009, Rasilez also received approval in Japan. Tekturna HCT, a single-pill combination of aliskiren and hydrochlorothiazide, was approved in the US in January 2008 for second-line treatment of high blood pressure, and in July 2009 for first-line treatment of high blood pressure. The single-pill combination Rasilez HCT was approved in the European Union in January 2009. In September 2009, Valturna, a single-pill combination of aliskiren and valsartan (Diovan), was approved in the US. Other single-pill combinations with aliskiren are currently in development including a single-pill combination with amlodipine.