Core Viewpoint - The FDA's recent update to fenofibrate drug labeling highlights the lack of cardiovascular benefits and aims to shift clinical practices towards therapies that are clinically proven to reduce cardiovascular events [1][2][3] Company Perspective - Amarin Corporation supports the FDA's decision, emphasizing the need for healthcare practitioners to stop prescribing fibrates for cardiovascular risk reduction, particularly in combination with statins, as this approach is outdated and ineffective [5][6] - The company advocates for the use of FDA-approved therapies like VASCEPA (icosapent ethyl) to reduce cardiovascular risks in patients with elevated triglycerides [6][10] Industry Context - Cardiovascular disease (CVD) is the leading cause of death globally, accounting for over 900,000 deaths annually in the U.S. and nearly 20 million worldwide [2] - Despite evidence from major clinical trials (FIELD, ACCORD Lipid, PROMINENT) showing that fenofibrates do not reduce cardiovascular event risks, over 11 million prescriptions were written in the U.S. in 2023, indicating a significant gap in clinical practice [3][4] - In Europe, fibrates are the third most commonly used lipid management agents, with an estimated two million patients treated with fibrates in Western Europe [4] Clinical Evidence - The FDA's labeling change is based on decades of clinical data demonstrating that fenofibrates do not provide cardiovascular benefits, even when used with statins [3] - The company highlights the importance of aligning treatment decisions with current scientific understanding to improve patient outcomes in cardiovascular health [7]