FDA approval for Diovan (Valsartan)

Aug 4 2005

Novartis Pharmaceuticals Corporation announced today that the US Food and Drug Administration (FDA) approved Diovan (valsartan), the most prescribed ARB (angiotensin receptor blocker) in the US and worldwide, for a new indication to reduce cardiovascular death in patients at high risk (with left ventricular failure or left ventricular dysfunction) following a heart attack.

The FDA also expanded the drug's heart failure labeling. Diovan can now be prescribed in a broader range of heart failure patients and is no longer limited to those intolerant of ACE inhibitors.

"Millions of patients already rely on Diovan to help them get to goal and maintain healthier blood pressure goals. Now, based on results from one of the largest mega-trial programs in the ARB class, Diovan has demonstrated additional benefits that can address the needs of an even broader spectrum of cardiovascular patients," said Alex Gorsky, Chief Operating Officer, Novartis Pharmaceuticals Corporation. "We remain committed to developing the full clinical potential of this agent."

High blood pressure, a disease which affects more than 65 million Americans, greatly increases the risk of suffering a heart attack or developing heart failure. Each year, 1.2 million Americans suffer a heart attack, which puts them at greater risk of repeat attacks or death. Patients who have experienced a heart attack may also progress to heart failure. In fact, within six years, nearly one-third of heart attack survivors will be disabled with heart failure, a progressive condition in which the heart's muscle weakens after injury from other cardiovascular conditions such as a heart attack or high blood pressure.

"Every day, more than 3,000 patients suffer a heart attack in the United States. While we've made significant advances in recent years, death following a heart attack remains unacceptably high," said Marc Pfeffer, MD, PhD, professor of medicine at Harvard Medical School, interim chair of medicine at Brigham and Women's Hospital, Boston, and the chair of the VALIANT (VALsartan In Acute myocardial iNfarcTion) trial, the study that led to the FDA's approval. "VALIANT was a tremendous scientific undertaking involving more than 14,000 patients in 24 countries. We are proud it has resulted in the approval of a new treatment to help improve the survival of patients at high risk following a heart attack."