Drug approval process for acute heart failure syndrome in the United States

The history of drug approval that targets the heart failure (HF) population has been subject to the advancements that have been made in the field of HF. A better understanding of the pathophysiology of the HF syndrome, with its complexity and an ever-growing number of patients, has led to an evolution in thinking at the Food and Drug Administration (FDA) Division of Cardiovascular and Renal Products. Once thought of as a terminal disorder without much hope even of palliation, heart failure therapies have emerged as powerful agents that can impact mortality and morbidity and may alter the course of the disease. The therapeutic choices through the years have targeted the concepts that were in vogue in each era. As an example, when inotropic derangement was thought to be the primary cause of HF, several inotropic therapies emerged and were approved based on a small amount of data.1 As the neurohormonal hypothesis was tested, drugs were targeted to this important axis, and the mortality and morbidity improved.