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Supplemental NDA Filed for Valsartan To Expand Label

EAST HANOVER, N.J., Dec. 22 /PRNewswire-FirstCall/ -- 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 to have these proven cardiovascular benefits of an ACE inhibitor.

The findings of VALIANT were consistent across all study endpoints and patient subgroups, regardless of age, gender, race, co-existing medical conditions (e.g., diabetes), or background medications, including beta blockers. VALIANT also studied the effects of Diovan in combination with captopril vs. captopril alone. The combination of valsartan and captopril had similar overall results adding no additional mortality benefit above monotherapy. No further benefits were seen in patients who took combination therapy. There was no added mortality and no added cardiovascular morbidity in patients who took a beta blocker, Diovan and the ACE inhibitor.

VALIANT is part of the Diovan clinical research program, already one of the world's largest with a cardiovascular agent, designed to involve 50,000 patients, including 8,000 patients with diabetes, in several ongoing trials investigating potential new applications for Diovan across the cardiovascular continuum from pre-diabetes (impaired glucose tolerance) to heart failure. The next trial to report will be VALUE (Valsartan Antihypertensive Long-Term Use Evaluation), a head-to-head comparison of Diovan vs. amlodipine (a leading calcium channel blocker) in 15,314 hypertensive patients with at least one additional risk factor for cardiovascular events.

In VALIANT, discontinuations due to adverse events were lowest in the valsartan group and highest in the combination group. Hypotension and renal side effects were most common in the group that received both medications together than in either group receiving valsartan or captopril alone. The rate of hypotension and renal dysfunction was slightly higher in the valsartan group than in the captopril group. Reducing the dose of study drug allowed a majority of patients who experienced hypotension or renal dysfunction to continue on study medication, and thus remain on life-saving therapy. Overall, there was a statistically significant higher rate of patient discontinuations due to adverse events in the captopril group where more treatment-limiting side effects occurred, including cough, rash and taste disturbance, compared to the valsartan group.

Diovan is currently indicated for the treatment of hypertension. It is also indicated for the treatment of heart failure in patients who are intolerant to ACE (angiotensin-converting-enzyme) inhibitors. Filings for the new indication will also be initiated with health authorities in major international markets. Diovan is already the leading drug in its class (angiotensin II receptor blocker, or ARB) for the treatment of high blood pressure and the second leading antihypertensive agent worldwide.

All ARBs and ACE inhibitors carry a warning that the drug should not be used in pregnant women due to the risk of injury and even death to the fetus. In patients with heart failure, concomitant use of Diovan, an ACE inhibitor and a beta blocker is not recommended. In Val-HeFT, this triple combination was associated with an unfavorable heart failure outcome. Because of the risk of hypotension, caution should be observed when initiating therapy in post-myocardial infarction patients and heart failure patients. Evaluation of post-myocardial infarction and heart failure patients should always include assessment of renal function. The most common side effects in heart failure patients with Diovan were dizziness, hypotension and diarrhea.

For more information or for full prescribing information for Diovan go to "Prescribing Info/Quick Download" at www.pharma.us.novartis.com or call Anna Frable at (862) 778-5388 or Kim Callahan Fox at (862) 778-7692.

Source: Novartis Pharmaceuticals Corporation

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