Novartis: Japanese Ministry of Health approves Rasilez

A first-in-class direct renin inhibitor (DRI), for the treatment of high blood pressure

09-Jul-2009 - Japan

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.

"In Japan, nearly 70% 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."

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.

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