Novartis' biggest selling drug Diovan has received US approval for a new indication, as it strives to bolster its position in the competitive cardiovascular market.

Diovan (valsartan) is the first drug in the angiotensin receptor blocker (ARB) class to gain a US licence for use in reducing cardiovascular death amongst high-risk heart attack survivors.

The FDA approval follows positive results from the VALIANT (Valsartan In Acute Myocardial Infarction) trial, one of the most rigorous studies ever conducted in post-myocardial infarction (MI) patients.

The trial involved more than 14,500 patients and compared Diovan with angiotensin converting enzyme (ACE) inhibitor captopril, with Novartis' drug shown to improve survival and reduce cardiovascular events including recurrence of heart attack.

Commenting on its latest indication, Alex Gorsky, Novartis' chief operating officer, said: "Millions of patients already rely on Diovan to help them get to goal and maintain healthier blood pressure goals. Now, based on results from one of the largest mega-trial programmes in the ARB class, Diovan has demonstrated additional benefits that can address the needs of an even broader spectrum of cardiovascular patients."

Diovan received a similar licence in Europe late last year and will be hoping its new US approval will help it gain ground on Pfizer's ageing calcium blocker Norvasc, marketed as Istin in the UK.

Diovan registered first half sales of nearly $1.9 billion, a leap of nearly 19% from last year, but still trails Norvasc which recorded sales of over $2.3 billion in the same period.

Merck's Cozaar, another competing ARB, has also seen its sales rise to over $1.5 billion in the first six months of 2005.

Meanwhile, the FDA also expanded Diovan's heart failure labelling. The drug can now be prescribed in a broader range of heart failure patients and is no longer limited to those intolerant of ACE inhibitors.

High blood pressure affects more than 65 million Americans and greatly increases the risk of heart attack or developing heart failure. Over one million Americans suffer a heart attack each year, putting them at greater risk of repeat attacks or death.

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Thursday , December 02, 2004

pharmafocus@wiley.co.uk