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European approval for 3-in-1 version of Exforge

Published on 23/10/09 at 11:24am

European regulators have approved an expanded version of Novartis' high blood pressure treatment Exforge.

Exforge was first approved in Europe in 2007 as a 2-in-1 combination of Novartis' own angiotensin II receptor blocker Diovan (valsartan) and calcium channel blocker amlodipine - the now off-patent Istin/Norvasc from Pfizer.

Exforge HCT adds the diuretic hydrochlorothiazide to the mix, producing a 3-in-1 combination the company hopes will prove popular with prescribers for its patient compliance benefits.

The company said up to 85% of patients could need multiple medications to help control their blood pressure, which underscores the need for more effective combination treatments.

Chief executive of Novartis' Pharmaceuticals Division Joe Jimenez said: "Novartis is committed to helping patients improve their treatment compliance. Simplified treatment regimens and reduced pill burdens have been shown to help achieve this.

"We are pleased that with the approval of Exforge HCT, a new 3-in-1 treatment for high blood pressure is now available to patients in the EU. With Diovan as the foundation of this new therapy, we are confident that it will become an important new treatment option."

Exforge HCT is indicated for substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of Diovan, amlodipine and hydrochlorothiazide, taken separately or as Exforge plus HCT.

Exforge HCT was approved by US regulator the FDA in April for the second-line treatment of high blood pressure, and in September the combination won a licence in Switzerland to treat patients whose blood pressure is not adequately controlled by dual therapy.

High blood pressure, or hypertension, is one of the most important but treatable risk factors for cardiovascular disease - the number one cause of death worldwide.

This makes it an attractive, but highly competitive, market for the pharmaceutical industry.

Novartis' Diovan is currently the top-selling blood pressure drug worldwide and the company's highest earner, raking in $5.7 billion in annual sales in 2008.

But it goes off-patent in the US, the world's largest pharma market, from 2012 and Exforge and Exforge HCT could help protect some of these sales from the generic onslaught Diovan's sales will inevitably face.

Novartis is also taking the combination route with Valturna, which brings together Diovan and its follow-up product Tekturna/Rasilez (aliskiren) and was recently approved in the US.

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