Novartis drug diovan nears FDA approval for hypertension

Drug Store News, Nov 19, 2001 by James Frederick

Novartis received an "approvable" letter from the FDA for Diovan (valsartan) for the treatment of heart failure in patients not taking ACE inhibitors. Final approval, according to Novartis, hangs on further analysis of existing data or the submission of additional data. Diovan is a highly selective angiotensin II receptor blocker already approved for first-line treatment of hypertension in more than 80 countries, including the United States, and is one of the fastest-growing branded prescription antihypertensives.

An estimated 3 million patients worldwide take Diovan for high blood pressure. Heart failure, or progressive weakening of the heart muscle, is the fastest-growing cardiovascular disease in the world and has reached epidemic proportions in industrialized nations. Twenty million people worldwide have heart failure, and the condition is the most common reason why patients aged 65 or older are hospitalized.