Novartis receives FDA approval for LESCOL XL 80 mg

New Formulation Provides Effective Treatment for Patients with Cholesterol, Triglyceride and other Lipid Disorders

EAST HANOVER, New Jersey - Novartis Pharmaceuticals Corporation today announced approval by the U.S. Food and Drug Administration for LESCOL XL (fluvastatin sodium) 80 mg, an extended-release tablet formulation of fluvastatin, a therapy that provides effective management of all major lipid parameters for patients with a variety of lipid disorders that place them at risk for heart disease. Phase III clinical trials demonstrate that LESCOL XL 80 mg produced up to 38 percent median decrease in low-density lipoprotein cholesterol (LDL-C) in patients with dyslipidemia, and a 25 percent median decrease in triglycerides (TG) and a 13 percent mean increase in high-density lipoprotein cholesterol (HDL-C) in patients with primary mixed dyslipidemia (Fredrickson Type IIb), as compared with LESCOL (fluvastatin sodium) 40 mg therapy.

"Physicians can use LESCOL XL as a starting dose to help patients effectively manage all major lipid parameters," said Paulo Costa, president and chief executive officer, Novartis Pharmaceuticals Corporation. "Phase III data demonstrate that this new formulation has the potential to bring the majority of patients who require statin therapy to their treatment goals."

For patients who have lipid disorders that place them at risk for heart disease, more than 90 percent can meet their treatment goals, as defined by the clinical application of the National Cholesterol Education Program (NCEP), by achieving a reduction of less than 30 percent in their LDL-C levels, according to empirical data from the National Health and Nutrition Examination Survey (NHANES III). The National Heart, Lung, and Blood Institute created the NCEP to contribute to reducing illness and death from coronary heart disease in the United States by reducing the percent of Americans with high blood cholesterol.


Contact: Anna Frable
Porter Novelli

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