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EU approves new BP drug

28th August 2007

European drug regulators have approved a new medication for high blood pressure, or hypertension, which affects millions of people across the EU.

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The direct renin inhibitor, Rasilez (generic name, aliskiren), is made by Swiss-based pharmaceutical manufacturer Novartis, which developed it in partnership with Speedel.

It is the first blood pressure therapy to target the enzyme responsible for hypertension, renin, Novartis said in a statement on its website.

The European Commission approved the drug for use in its member states alone or in combination with other medicines, after reviewing data from 44 clinical trials of the drug, involving 7,800 patients.

The approval covers all 27 member states, plus Iceland and Norway.

Novartis claims Rasilez can lower blood pressure significantly over a 24 hour period, an effect which current medications find it difficult to achieve.

The company quoted studies which showed that almost 70% of the world's estimated one billion hypertensive patients had not achieved treatment goals.

Roland Schmieder, Professor of Medicine at the University of Erlangen-Nuremberg, Germany, said the trial results were promising.

Complications from high blood pressure can include heart attack, stroke, kidney failure, blindness and death.

Novartis said Rasilez would provide an additional therapy choice for patients already on medication, but whose blood pressure was still too high.

An additional benefit was seen when Rasilez was added to ACE inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers (CCBs) or HCT, it added.

Many currently available high blood pressure medicines fail to work around the clock, especially during the early morning hours when blood pressure often surges.

Hypertension occurs when the blood in the body moves through the blood vessels at a higher pressure than normal and causes damage to the arteries, kidneys, brain and other vital organs that can ultimately lead to heart failure.

 

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