FDA priority review for Novartis' Diovan in heart failure

The US Food and Drug Administration has granted priority review statusto Novartis' supplemental New Drug Application for its antihypertensive Diovan (valsartan) for the treatment of heart failure. The company says that this is the first angiotensin II receptor blocker to seek an indication beyond hypertension in the USA.

The new indication application, which has also been filed with other regulatory agencies, is based on the positive findings of the Valsartan Heart Failure Trial, which showed that Diovan significantly reduced morbidity by 13.2% and hospitalization by 27.5% versus placebo in heart-failure patients taking usual prescribed therapy. The benefits observed with Diovan were incremental to those of usually prescribed therapy.

Diovan, which is a main driver of Novartis' growth and produced sales of 1.23 billion Swiss francs ($681.4 million) in 2000 for the company, is forecast by Morgan Stanley Dean Witter analysts to achieve turnover of 4.07 billion francs by 2007.