Japanese Ministry Of Health Approves Rasilez(R), A First-in-class Direct Renin Inhibitor (DRI), For The Treatment Of High Blood Pressure

Main Category: Hypertension
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 09 Jul 2009 - 2:00 PDT

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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 renin9, 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 worldwide10. In Japan an estimated 40 million people, nearly a third of the population, are affected by high blood pressure7 with the majority of patients not reaching their blood pressure treatment goal8.

"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."

It is estimated that nearly one billion people globally have high blood pressure11 and many of these remain either untreated or treated but not reaching their target11. 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 therapies11.

Rasilez, known as Tekturna® in the US*, works by directly inhibiting renin to reduce the effects caused by an over-active renin system9. By inhibiting renin at the point of activation, Rasilez provides significant blood pressure reductions alone or in combination with other antihypertensives3-6.

The potential long-term benefits of Rasilez are currently being investigated further in the landmark ASPIRE HIGHER program, the largest ongoing cardio-renal outcomes program 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, MD, 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.

References

1 Oh BH, et al. Aliskiren, an Oral Renin Inhibitor, Provides Dose-Dependent Efficacy and Sustained 24-hour Blood Pressure Control in Patients with Hypertension. J Am Coll Cardiol 2007; 49:1157-63.

2 Palatini P, et al. Blood Pressure Reduction Following A Simulated Missed Dose Of Aliskiren, Irbesartan, or Ramipril: A Comparative Ambulatory Blood Pressure Monitoring Study. Presentation at American Society of Hypertension 2008.

3 Uresin Y, et al. Aliskiren Monotherapy Lowers Blood Pressure More Effectively than Ramipril Monotherapy in Patients with Diabetes and Grade 2 Hypertension: Subgroup Analysis of an 8-week, Double-Blind Trial. J Hypertens 2008: 26 (Suppl 1): S479 PS33/THU/62.

4 Oparil S, Yarows SA, Patel S, Fang H, Zhang J, Satlin A. Efficacy and Safety of Combined use of Aliskiren and Valsartan in Patients with Hypertension: A Randomised, Double-Blind Trial. Lancet 2007; 370:221-29.

5 Drummond W, et al. Antihypertensive Efficacy of the Oral Direct Renin Inhibitor Aliskiren as Add-on Therapy in Patients not Responding to Amlodipine Monotherapy. J Clin Hypertens 2007;9:742-50. 6 Gradman A, et al. Aliskiren in Combination with Hydrochlorothiazide is Effective and well Tolerated during Long-Term Treatment of Hypertension. Presentation at the American Society of Hypertension 2007.

7 National Health and Nutrition Survey Report Japan, 2006.

8 Fujita T et al. Current situation and issue on medication for hypertension and hyperlipidemia: Progress Medicine 26: 2297-2306,2006.

9 Tekturna® (aliskiren) Prescribing Information. Available at: http://www.tekturna.com.

10 World Health Organization. Cardiovascular disease factsheet. Available at: http://www.who.int/mediacentre/factsheets/fs317/en/index.html. Last accessed April 2009.

11 Chobanian AV et al. Seventh Report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension 2003;42:1206-51.

* Rasilez® is the trade name for aliskiren throughout the world, except in the US where it is known as Tekturna®.

Source
Novartis