New blood pressure drug Rasilez approved in Europe
pharmafile | August 30, 2007 | News story | Sales and Marketing |Â Â Â
New high blood pressure medication Rasilez has been approved in Europe, with its marketers Novartis claiming it is the first major innovation in the field for more than a decade.
Analysts have predicted worldwide peak sales forecasts for Rasilez (aliskeren) as high as $3.5 billion, but the drug must first convince doctors of its superiority to existing treatments in a highly competitive market.
First in a new class called direct renin inhibitors, Rasilez directly targets the source of high blood pressure and Novartis says the drug outperforms current standard therapies such as ACE inhibitors and the diuretic hydrochlorothiazide.
Around 70% of patients on high blood pressure medication do not currently reach their treatment goals, and Novartis hopes that specialists and general practitioners will prescribe the drug to help patients reach their target.
The drug is licensed to for use alone and in combination with existing hypertension medicines of all classes.
Another key claim for the drug is that lowers blood pressure consistently for 24 hours and beyond. Novartis wants to point out the advantage over existing treatments, many of which fail to work around the clock, especially during the early morning period when dangerous blood pressure surges often occur.
"Rasilez is the first medicine to directly target high blood pressure at its source, the enzyme renin," said Dr. Roland Schmieder, Professor of Medicine at the University of Erlangen-Nuremberg, Germany.
"As doctors, our biggest challenge is getting blood pressure under control in the first place and then keeping it there. Because Rasilez works well alone or with other medicines, it shows good promise in helping patients, even those who haven't yet achieved control with other medicines."
Novartis is looking to provide further evidence of Rasilez's superiority. The long-term potential of Rasilez and direct renin inhibition is being studied in a trial programme named ASPIRE HIGHER, looking at the effects of the drug in high blood pressure patients with heart failure or kidney failure. Data from trials are expected to be released later this year.
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