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BY OUR PHARMA CORRESPONDENT
5 August, 2005: Novartis has received the US Food and Drug Administration’s approval for Diovan (valsartan) 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 company announced.
Valsartan is currently one of the most prescribed ARB (angiotensin receptor blocker) worldwide.
The FDA also expanded the drug's heart failure labelling. Diovan can now be prescribed in a broader range of heart failure patients and is no longer limited to those intolerant of ACE inhibitors. The US approval follows shortly after marketing authorizations were granted for Diovan in 14 EU member states and other countries around the world to treat people who survived a recent heart attack and people with heart failure.
"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.
VALIANT study involved more than 14,000 patients in 24 countries, the release said.
High blood pressure, a disease which affects one billion people globally, greatly increases the risk of suffering a heart attack or developing heart failure. People who have suffered a heart attack are at greater risk of repeat attacks or death and 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.
The approvals of Diovan to reduce cardiovascular death in high-risk heart attack survivors are based on the results of VALIANT, one of the largest, long-term studies ever conducted in people who have suffered a heart attack. VALIANT was a rigorous comparison of Diovan vs. captopril (an ACE inhibitor) vs. the combination of both in 14,703 patients at high risk for death following a heart attack.
In the VALIANT trial Diovan was reported to improve survival and reduce cardiovascular events including recurrent heart attack and hospitalizations for heart failure in these patients. There were no differences observed in overall mortality among the treatment groups. The results of VALIANT were published in the peer-reviewed journal, the New England Journal of Medicine, and presented at the American Heart Association Scientific Sessions in November 2003.
One of the most prescribed antihypertensives in the world today, Diovan is available as a first-line treatment for high blood pressure in more than 90 countries, for the treatment of heart attack survivors in nearly 50 countries and in 70 countries for the treatment of people with heart failure. Additional marketing authorization applications are pending for the treatment of post-heart attack and heart failure.
For high-risk heart attack patients, Diovan recently completed the EU Mutual Recognition Procedure (MRP) in 14 countries for the treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent myocardial infarction. In the US, Diovan is indicated to reduce cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction.
For heart failure, Diovan also completed an EU type II variation application in 14 countries for the treatment of people with symptomatic heart failure when ACE inhibitors can not be used, or as add-on therapy to ACE inhibitors when beta blockers can not be used. In the US, Diovan is indicated for the treatment of heart failure (NYHA class II-IV), the release added.
Headquartered in Basel, Switzerland, Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Novartis Group companies employ about 83,700 people and operate in over 140 countries around the world.
BY OUR PHARMA CORRESPONDENT
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