Document Type
Article
Publication Date
2021
Keywords
NT-proBNP, PARADIGM-HF, PARAGON-HF, Pediatric Heart Failure, Postmarketing Requirements, Sex Differences
Abstract
Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying its market approval. Using information extracted from Entresto's online approval package at Drugs@FDA, we explore some of the procedural complexities underlying market approval of new pharmaceuticals, discuss the broad pharmacological implications contained within regulatory agency grey literature, and highlight opportunities for future therapeutic development.
Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-No Derivative Works 4.0 International License.
Recommended Citation
Ashley L Eadie, Keith R Brunt & Matthew Herder, "Exploring the Food and Drug Administration’s Review and Approval of Entresto (Sacubitril/Valsartan)" (2021) 9:3 Pharmacology Research & Perspectives e00794.
Included in
Food and Drug Law Commons, Health Law and Policy Commons, Medical Jurisprudence Commons, Science and Technology Law Commons
