Novartis is celebrating after winning European approval for one of its key products – Diovan (valsartan) – in the treatment of heart failure. The extended approval significantly opens up the market for this drug, which already brings in annual sales in excess of $3 billion dollars [[21/01/05a]], as more than 4.5 million Europeans suffer from heart failure.
The Swiss giant says that the hypertensive is the only agent of its kind indicated to treat both heart attack survivors and people with heart failure, after winning the nod in the former indication last month [[09/05/05a]]. It is now specifically indicated for people with symptomatic heart failure when an ACE inhibitor drug cannot be used, or as add-on therapy to ACE inhibitors when beta-blockers cannot be used.
The new heart failure indication is based on data from the Val-HeFT, which showed that Diovan reduced combined mortality and morbidity by 13% in heart failure patients also taking standard therapy, including a 33% reduction in mortality in heart failure patients not taking ACE inhibitors.
Heart failure occurs when the heart, after becoming damaged by a heart attack, high blood pressure or other conditions, loses its ability to pump enough blood through the body. Nearly eight million people suffer from heart failure and 600,000 new cases are reported every year in the EU.