News - Hypertension Week of January 4, 2004, Vol. 3 No. 01

FDA Asked to Approve Diovan for as Therapy for Heart Attack Sufferers

Novartis Pharmaceuticals has asked the U.S. Food and Drug Administration (FDA) to approve its high blood pressure drug Diovan® (valsartan) as a treatment for improving survival and reducing cardiovascular events in those who have had heart attack.

Besides treating high blood pressure, Diovan, an angiotensin II receptor blocker, is already approved for the treatment of heart failure in patients who are intolerant to ACE inhibitors.

The new filing is based on positive results from a recent trial that found Diovan to be as effective in prolonging survival after heart attack and reducing recurrent heart attacks and hospitalizations as the ACE inhibitor captopril, an accepted standard of treatment.

According to Novartis, Diovan is the only cardiovascular agent ever demonstrated by a head-to-head study to have these proven cardiovascular benefits of an ACE inhibitor.

Novartis said it would soon report results from a trial comparing Diovan with the leading calcium channel blocker amlodipine in hypertensive patients with at least one additional risk factor for cardiovascular events.

Other sources: Novartis