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Review
. 2019 Dec;106(6):1222-1235.
doi: 10.1002/cpt.1540. Epub 2019 Jul 23.

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

Aernout van Haarst  1 , Lorcan McGarvey  2 , Sabina Paglialunga  1
Affiliations
Review

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

Aernout van Haarst et al. Clin Pharmacol Ther. 2019 Dec.

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.

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Conflict of interest statement

A.v.H. and S.P. are employees of Celerion. L.M.G. has received consultancy and lecture fees from Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Merck, Bionorica, Afferent, Celerion, Bellus Health, and Bayer.

Figures

Figure 1
Figure 1
Timeline of chronic obstructive pulmonary disease (COPD) drug approvals. The timeline depicts the COPD drugs by class and year of first approval in either the US and/or the European Union market. Publication year of regulatory guidance is also shown. ABECB, acute bacterial exacerbations of chronic bronchitis; E‐RS‐COPD, evaluating respiratory symptoms in COPD; EXACT, Exacerbations of Chronic Pulmonary Disease Tool; ICS, inhaled corticosteroids; LABA, long‐acting β2‐adrenoreceptor; LAMA, long‐acting muscarinic antagonists; PDE4, phosphodiesterase type 4; SABA, short‐acting β2‐adrenoreceptor agonist; SAMA, short‐acting muscarinic antagonist; SGRQ, St. George's Respiratory Questionnaire.
Figure 2
Figure 2
Chronic obstructive pulmonary disease (COPD) drug pipeline. The COPD indication pipeline is robust with a number of novel mechanisms and targets. Listing obtained from Clarivate Analytics Cortellis (Philadelphia, PA) database and literature review.17 CFTR, cystic fibrosis transmembrane conductance regulator; MARCKS, myristoylated alanine‐rich C‐kinase substrate; NK, natural killer.
See this image and copyright information in PMC

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