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.
| Original language | English |
|---|---|
| Article number | e00794 |
| Journal | Pharmacology Research and Perspectives |
| Volume | 9 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Jun 2021 |
Bibliographical note
Funding Information:This research was supported by a grant from the Canadian Institutes of Health Research (CIHR PJT 1522656).
Publisher Copyright:
© 2021 The Authors. Pharmacology Research & Perspectives published by British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics and John Wiley & Sons Ltd.
ASJC Scopus Subject Areas
- Neurology
- Pharmacology, Toxicology and Pharmaceutics(all)
PubMed: MeSH publication types
- Journal Article
- Research Support, Non-U.S. Gov't
- Review