Disease Analysis: Chronic Obstructive Pulmonary Disease (COPD)
Author: Pammy Spicer
Publisher: Datamonitor Healthcare
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Disease Overview
Chronic obstructive pulmonary disease (COPD) is defined by persistent airflow limitation (reduction in the ability to exhale at a normal rate and volume). While chronic and progressive dyspnea (shortness of breath) is a key symptom, patients may also present with productive cough. Significant exposure to noxious particles or gases, namely tobacco smoke, is the primary cause of the underlying alveolar and airway abnormalities that result in the airflow limitation and respiratory symptoms that characterize the disease. However, other environmental and occupational exposures or genetic abnormalities may also contribute to symptoms
Latest key takeaways
- Datamonitor Healthcare estimates that in 2021, there were approximately 314.8 million prevalent cases of chronic obstructive pulmonary disease (COPD) worldwide, and forecasts that number to increase to 328.9 million prevalent cases by 2027.
- The “ABCD” GOLD treatment guidelines focus on exacerbation risk and patient-reported outcomes to determine pharmacological treatment strategies, independent of spirometric value.
- Dual bronchodilator combinations are being considered as the new gold standard over long-acting muscarinic antagonist (LAMA) Spiriva in the treatment of more severe COPD.
- Triple inhaled corticosteroid/long-acting beta 2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) fixed-dose combination therapies delivered through a single inhaler bring convenience to more severe patients. For Breztri Aerosphere’s FDA submission, AstraZeneca included data from the KRONOS study, but the ETHOS trial did not complete primary endpoints until mid-2019. As such, the FDA issued a complete response letter to AstraZeneca, benefiting rival GlaxoSmithKline’s marketed Trelegy Ellipta as the only triplet on the US market. More recently, Breztri has gained approval in the US and Europe.
- IL-5 inhibitors have been disappointing in the broader population of more severe COPD patients. However, ongoing studies are evaluating AstraZeneca’s Fasenra and GlaxoSmithKline’s Nucala in individuals with high eosinophils. Topline results from Fasenra’s RESOLUTE and Nucala’s MATINEE trials are expected in the coming years, as are Phase III results from Sanofi and Regeneron’s dual IL-4 and IL-13 inhibitor Dupixent.
- Nebulizers are limited by convenience and often are being developed by smaller companies that lack the commercial resources of large pharma.
CONTENTS
6 OVERVIEW
6 Latest key takeaways
7 DISEASE BACKGROUND
7 Disease definition
7 Diagnosis
7 Patient segmentation
11 TREATMENT
11 GOLD treatment recommendations
11 Maintenance treatment
15 Oral therapies for maintenance treatment
15 Non-pharmacological management of COPD
16 EPIDEMIOLOGY
16 Prevalence methodology
19 MARKETED DRUGS
27 PIPELINE DRUGS
33 KEY REGULATORY EVENTS
33 Viatris Wins First US Symbicort Generic – Will It Launch At Risk?
33 New Drugs For Smallpox, Migraine, COPD And Obesity
33 Stada’s Thornton & Ross Rivals Seretide In UK
33 After Lupin Launch, Cipla Introduces US Brovana Rival
34 Teva Capitalizes On Patent Expiry To Launch First Perforomist Rival
34 Glenmark Fulfills Promise To Introduce Tiotropium In Europe
34 Lupin Gets Another First With Fostair
35 Lupin Gets Head Start On Brovana With US Authorized Generic
36 PROBABILITY OF SUCCESS
37 LICENSING AND ASSET ACQUISITION DEALS
37 Cantex To Team Up With Harvard University To Develop Azeliragon
37 Mankind Inks Second Acquisition In A Month, This Time With Dr. Reddy’s
37 Covis Pharma Enters Promotion And Distribution Agreement With Novartis Pharmaceuticals Canada
37 Lupin’s Deal For Soft-Mist Inhalation Tech Gives Access To Spiriva Respimat Platform
38 Chinese Firms Look Inward To Access Innovation
38 AstraZeneca Rejigs Respiratory Franchise With Fresh Covis Deal
38 Nuance Gets Greater China Rights To Verona COPD Candidate
40 CLINICAL TRIAL LANDSCAPE
41 Sponsors by status
42 Sponsors by phase
44 DRUG ASSESSMENT MODEL
44 LAMAs
45 LABAs
45 LABA/LAMAs
45 ICS/LABAs
46 ICS/LABA/LAMAs
46 Pipeline biologics
47 Phosphodiesterase (PDE) inhibitors
49 MARKET DYNAMICS
50 FUTURE TRENDS
50 Triple therapies will drive modest growth of the COPD market
50 The impact of nebulized treatment is limited
50 Biologics present an opportunity that is limited to certain patient subsets
51 CONSENSUS FORECASTS
56 KEY UPCOMING EVENTS
57 UNMET NEEDS
57 Characterizing patient subpopulations
57 Developing more effective means of managing exacerbations
57 Improving inhaler technique and compliance
58 BIBLIOGRAPHY
59 APPENDIX
LIST OF FIGURES
18 Figure 1: Trends in prevalent cases of COPD, 2018–27
27 Figure 2: Overview of pipeline drugs for COPD in the US
27 Figure 3: Pipeline drugs for COPD, by company
28 Figure 4: Pipeline drugs for COPD, by drug type
28 Figure 5: Pipeline drugs for COPD, by classification
36 Figure 6: Probability of success in the COPD pipeline
40 Figure 7: Clinical trials in COPD
40 Figure 8: Top 10 drugs for clinical trials in COPD
41 Figure 9: Top 10 companies for clinical trials in COPD
41 Figure 10: Trial locations in COPD
42 Figure 11: COPD trials status
43 Figure 12: COPD trials sponsors, by phase
44 Figure 13: Datamonitor Healthcare’s drug assessment summary for COPD
49 Figure 14: Market dynamics in COPD
50 Figure 15: Future trends in COPD
56 Figure 16: Key upcoming events in COPD
LIST OF TABLES
8 Table 1: Modified British Medical Research Council (mMRC) Questionnaire
9 Table 2: COPD Assessment Test (CAT)
10 Table 3: COPD assessment, by spirometric grade
11 Table 4: The “ABCD” assessment tool
12 Table 5: Inhaled bronchodilators for COPD, by class
15 Table 6: Combination therapies for COPD, by class
17 Table 7: Prevalent cases of COPD, 2018–27
20 Table 8: Marketed drugs for COPD
29 Table 9: Pipeline drugs for COPD in the US
52 Table 10: Historical global sales, by drug ($m), 2017–21
54 Table 11: Forecasted global sales, by drug ($m), 2022–26
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