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Review of Drug Development Guidance to Treat Chronic Obstructive Pulmonary Disease: US and EU Perspectives
Author(s) -
Haarst Aernout,
McGarvey Lorcan,
Paglialunga Sabina
Publication year - 2019
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1540
Subject(s) - medicine , drug development , copd , intensive care medicine , clinical trial , context (archaeology) , biomarker , pulmonary disease , disease , drug , population , pharmacology , environmental health , paleontology , biochemistry , chemistry , biology
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.