FDA Approves Diovan to Reduce Cardiovascular Death

EAST HANOVER, N.J., August 3, 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."

New FDA approval based on landmark VALIANT trial

The FDA approval of Diovan to reduce cardiovascular death in high-risk heart attack survivors is 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.

A demonstrated commitment to improving patient care

Novartis is focused on improving the care of patients with high blood pressure and heart disease through world-class research and unprecedented public health initiatives. The Diovan clinical trial program represents an impressive research commitment across the cardiovascular continuum, which involves more than 55,000 patients. Recently completed Diovan trials include VALUE in high blood pressure patients; VALIANT in post-heart attack patients; and Val-HeFT in heart failure patients. Ongoing studies include the NAVIGATOR trial, examining whether long-term treatment with Diovan delays or prevents the progression to type 2 diabetes and/or cardiovascular events in 9,524 people with impaired glucose tolerance, and Val-MARC, a study of the effects of Diovan on C-reactive protein, an inflammatory marker for heart disease.

About Diovan

Diovan is indicated for the first-line treatment of hypertension and may be used over a dose range of 80 mg to 320 mg daily, administered once-a-day. Diovan 80 mg and 160 mg are both approved starting doses for hypertension. Diovan 160 mg is recommended for patients requiring greater blood pressure reductions (if they are not volume-depleted).

Based on the results of Val-HeFT, Diovan was the first drug in its class indicated to treat heart failure. For the treatment of heart failure, Diovan is available in 40 mg, 80 mg, and 160 mg tablets, dosed twice daily.

In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction (post-MI), Diovan is indicated to reduce cardiovascular mortality. The recommended starting dose for post-MI therapy is 20 mg twice daily (1/2 40 mg scored tablet) followed by up titration to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs consideration should be given to a dosage reduction.

Diovan should be discontinued as soon as pregnancy is detected because it may cause harm or even death to the unborn child.

Diovan is contraindicated for patients who are allergic to any of the ingredients of the product. Side effects in hypertension patients have generally been mild. The most common side effects with Diovan in hypertension patients are headache and dizziness. Volume and/or salt-depletion should be corrected in patients prior to administering Diovan or symptomatic hypotension may occur.

The most common side effects in heart failure patients with Diovan were dizziness, hypotension, and diarrhea. The most common side effects in post-MI patients which caused them to stop taking the drug were hypotension, cough, rash and an increase in serum creatinine levels. Because of the risk of hypotension, caution should be observed when initiating therapy in heart failure or post-MI patients. Evaluation of heart failure or post-MI patients should always include assessment of renal function.

Source: Novartis Pharmaceuticals Corporation

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