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Blood pressure treatment approved in Japan

Novartis' drug for treating high blood pressure, Rasilez, has been approved by the Japanese Ministry of Health, Labour and Welfare

Novartis' drug for treating high blood pressure, Rasilez (aliskiren), has been approved by the Japanese Ministry of Health, Labour and Welfare. It is a first-in-class direct renin inhibitor (DRI) providing significant blood pressure reductions. The benefits last for 24 hours when taken alone or in combination with other antihypertensives, and it is the first such treatment to be made available in more than a decade.

Rasilez works by directly inhibiting renin, an enzyme that triggers a process leading to high blood pressure and organ damage.

An estimated 40 million people in Japan, or nearly a third of the population, have high blood pressure.

"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." 

The potential long-term benefits of Rasilez are currently being investigated further in the ASPIRE HIGHER programme, the largest ongoing cardio-renal outcomes programme worldwide, involving more than 35,000 patients in 14 trials. 

Rasilez is approved in over 70 countries. It is marketed as Tekturna in the US, where it was approved in March 2007. As Rasilez it was approved in the European Union in August 2007. Tekturna HCT, the single-pill combination, was approved in the US in January 2008. The single-pill combination, Rasilez HCT was approved by the European Commission in January 2009. 

8th July 2009

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