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Novartis Files sNDA for its Leading High Blood Pressure Drug Diovan(R) to Improve Survival and Reduce Cardiovascular Events in High-Risk Patients Following a Heart Attack; Filing based on the positive results of VALIANT Trial.

Publication: PR Newswire
Publication Date: 22-DEC-03 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
Novartis Pharmaceuticals Corporation announced it has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for a new indication for Diovan(R) (valsartan) to improve survival and reduce cardiovascular events in patients at high risk after surviving a heart attack.

The new filing is based on the positive results of VALIANT (Valsartan in Acute Myocardial Infarction Trial), the largest long-term study ever conducted in post-heart attack patients which investigated 14,703 people. VALIANT demonstrated that Diovan prolongs survival after heart attack as effectively as the ACE inhibitor captopril, an accepted standard of treatment, and is at least as effective as the ACE inhibitor in reducing recurrent heart attacks and hospitalizations for heart failure in these patients. Diovan is the only cardiovascular agent ever demonstrated by a head-to-head study...

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