The U.S. Food and Drug Administration (FDA) approved Lescol (fluvastatin sodium) and Lescol XL (fluvastatin sodium) 80 mg extended-release tablets to reduce the risk of undergoing coronary revascularization procedures in patients with coronary heart disease. Reliant Pharmaceuticals LLC markets Lescol (fluvastatin sodium) and Lescol XL (fluvastatin sodium), extended release tablets developed by Novartis Pharmaceuticals Corporation and its affiliates for cholesterol management under an exclusive promotion agreement with Novartis Pharmaceuticals Corporation.
Each year approximately one million patients in the U.S. undergo percutaneous coronary intervention (PCI) procedures, such as angioplasty and stenting, to open blocked arteries. Of those patients, nearly 40 per cent will undergo a second procedure or have a heart attack within five years.
"Reliant is very excited about the implications of this new labeling enhancement for Lescol and Lescol XL. Through our exclusive promotion agreement with Novartis, Reliant has been very successful in communicating Lescol's safety and tolerability benefits to primary care and specialty physicians throughout the U.S.," said Dr. Ernest Mario, Chairman and Chief Executive Officer of Reliant. "This new indication represents the culmination of the first and only prospective evaluation of the long-term benefits of statin therapy in this particularly high risk population and further supports the safety and efficacy of Lescol."
The FDA approval is based on the positive findings of the landmark Lescol Intervention Prevention Study (LIPS), which demonstrated that treatment with Lescol 80 mg (40 mg twice daily), routinely initiated shortly after a first PCI procedure, significantly reduced the chances of a recurrent cardiac event by 22 per cent (p=0.013) versus placebo, even in patients with normal cholesterol levels with or without a history of myocardial infarction. Additionally, treatment with Lescol was associated with a 32 per cent (p=0.002) reduction in the risk of late revascularization procedures, defined as those procedures performed at any site more than six months after the initial procedure.
Both Lescol and Lescol XL 80 mg extended-release tablets have already been approved for a similar indication in several countries, including the United Kingdom and applications are pending in other markets.