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Drug Approval Process for Acute Heart Failure Syndrome in the United States

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Acute Heart Failure

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Abstract

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.

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Author information

Authors and Affiliations

  1. Department of Medicine, Case Western Reserve University, Cleveland, OH, USA

    Ileana L. Piña MD

  2. Division of Cardio-Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Springer London Ltd., Silver Spring, MD, USA

    Shari L. Targum MD

Authors
  1. Ileana L. Piña MD
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  2. Shari L. Targum MD
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Editor information

Editors and Affiliations

  1. Department of Anesthesiology and Critical Care Medicine, Lariboisière University Hospital, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, Paris, France

    Alexandre Mebazaa MD, PhD (Professor of Medicine) (Professor of Medicine)

  2. Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

    Mihai Gheorghiade MD, FACC (Professor of Medicine and Surgery, Associate Chief, Division of Cardiology and Chief, Cardiology Clinical Service) (Professor of Medicine and Surgery, Associate Chief, Division of Cardiology and Chief, Cardiology Clinical Service)

  3. Department of Cardiology Centre d’Investigation Clinique (CIC), INSERM U-684, Centre Hospitalier Universitaire, University Henri Poincaré, Nancy, France

    Faiez M. Zannad MD, PhD, FESC (Professor of Medicine) (Professor of Medicine)

  4. Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, Camden, NJ, USA

    Joseph E. Parrillo MD (Professor of Medicine, Chief, Department of Medicine Edward D. Viner MD Chair, Department of Medicine and Director) (Professor of Medicine, Chief, Department of Medicine Edward D. Viner MD Chair, Department of Medicine and Director)

  5. Cooper Heart Institute, Cooper University Hospital, Camden, NJ, USA

    Joseph E. Parrillo MD (Professor of Medicine, Chief, Department of Medicine Edward D. Viner MD Chair, Department of Medicine and Director) (Professor of Medicine, Chief, Department of Medicine Edward D. Viner MD Chair, Department of Medicine and Director)

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© 2008 Springer-Verlag London Limited

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Piña, I.L., Targum, S.L. (2008). Drug Approval Process for Acute Heart Failure Syndrome in the United States. In: Mebazaa, A., Gheorghiade, M., Zannad, F.M., Parrillo, J.E. (eds) Acute Heart Failure. Springer, London. https://doi.org/10.1007/978-1-84628-782-4_84

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  • DOI: https://doi.org/10.1007/978-1-84628-782-4_84

  • Publisher Name: Springer, London

  • Print ISBN: 978-1-84628-781-7

  • Online ISBN: 978-1-84628-782-4

  • eBook Packages: MedicineMedicine (R0)

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