Review of Drug Development Guidance to Treat Chronic Obstructive Pulmonary Disease: US and EU Perspectives

Aernout van Haarst, Lorcan McGarvey, Sabina Paglialunga

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)
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Abstract

Chronic obstructive pulmonary disease (COPD) remains a leading cause of death worldwide, yet only one new drug class has been approved in the last decade. However, resurgence in COPD treatment has been recently fueled by a greater understanding of the pathophysiology and natural history of the disease, as well as a growing prevalence and an aging population. Currently, there are nearly 25 novel drug targets in development. Furthermore, the indication has undergone some fundamental changes over the last couple of years, including an updated diagnosis paradigm, validation, and approval of patient-reported outcome questionnaires for clinical trials, and drug development tools, such as a prognostic biomarker for patient selection. In the context of clinical trials, this review aims to summarize recent changes to the diagnosis and evaluation of COPD and to provide an overview of US and European regulatory guidance.
Original languageEnglish
Pages (from-to)1222-1235
Number of pages14
JournalClinical Pharmacology and Therapeutics
Volume106
Issue number6
Early online date23 Jul 2019
DOIs
Publication statusEarly online date - 23 Jul 2019

Keywords

  • Pharmacology (medical)
  • Pharmacology

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