Novartis Pharma Rasilez Receives Chinese Approval

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.

According to Novartis, by inhibiting renin at the point of activation, Rasilez provides blood pressure reductions alone or in combination with other antihypertensives.

Novartis Pharma’s Rasilez/Tekturna is approved in over 80 countries. Tekturna has received FDA approval in March 2007 and European Union approval in August 2007 under the trade name Rasilez.

Rasilez received Japanese approval in July 2009. 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.

Novartis Pharma said that 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.

David Epstein, division head of Novartis Pharmaceuticals, said: “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. By adapting our development timelines for Rasilez we have been able to provide patients in China with timely access to this new therapy for high blood pressure.”