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 2018, there were approximately 307.0 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
7 OVERVIEW
7 Latest key takeaways
8 DISEASE BACKGROUND
8 Disease definition
8 Diagnosis
8 Patient segmentation
11 GOLD treatment recommendations
13 TREATMENT
13 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
32 KEY REGULATORY EVENTS
32 Glenmark Fulfills Promise To Introduce Tiotropium In Europe
32 Lupin Gets Another First With Fostair
32 Lupin Gets Head Start On Brovana With US Authorized Generic
32 Viatris Clears US Symbicort Hurdle But Loses Key Patent Fight To AstraZeneca
33 Hikma Launches Long-Awaited US Advair Rival
33 Trixeo Aerosphere Wins EMA Thumbs Up
33 US FDA Panel Rejects Trelegy Ellipta COPD Mortality Claim; Worries Include Potential Overuse
35 PROBABILITY OF SUCCESS
36 LICENSING AND ASSET ACQUISITION DEALS
36 China And US Added to Amneal-Iconovo Symbicort Alliance
36 Pulmatrix Reacquires All Rights to COPD Drug PUR1800
36 Sandoz Shakes Up US Albuterol Market With Proventil Deal
38 CLINICAL TRIAL LANDSCAPE
39 Sponsors by status
40 Sponsors by phase
41 Recent events
43 DRUG ASSESSMENT MODEL
43 LAMAs
44 LABAs
44 LABA/LAMAs
44 ICS/LABAs
45 ICS/LABA/LAMAs
45 Pipeline biologics
46 Pipeline PDE3/4 inhibitor
47 MARKET DYNAMICS
48 FUTURE TRENDS
48 Triple therapies will drive modest growth of the COPD market
48 The impact of nebulized treatment is limited
48 Biologics present an opportunity that is limited to certain patient subsets
49 CONSENSUS FORECASTS
54 RECENT EVENTS AND ANALYST OPINION
54 Trelegy Ellipta for COPD (August 31, 2020)
55 Trelegy Ellipta for COPD (August 28, 2020)
56 Breztri Aerosphere for COPD (June 24, 2020)
57 RPL554 (Inhaled) for COPD (March 31, 2020)
60 KEY UPCOMING EVENTS
61 UNMET NEEDS
61 Characterizing patient subpopulations
61 Developing more effective means of managing exacerbations
61 Improving inhaler technique and compliance
62 BIBLIOGRAPHY
63 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
35 Figure 6: Probability of success in the COPD pipeline
38 Figure 7: Clinical trials in COPD
38 Figure 8: Top 10 drugs for clinical trials in COPD
39 Figure 9: Top 10 companies for clinical trials in COPD
39 Figure 10: Trial locations in COPD
40 Figure 11: COPD trials status
41 Figure 12: COPD trials sponsors, by phase
43 Figure 13: Datamonitor Healthcare’s drug assessment summary for COPD
47 Figure 14: Market dynamics in COPD
48 Figure 15: Future trends in COPD
57 Figure 16: Breztri Aerosphere for COPD (June 24, 2020): Phase III – ETHOS
59 Figure 17: RPL554 (Inhaled) for COPD (March 31, 2020): Phase II – Metered-Dose Inhaler (MDI) Formulation
60 Figure 18: Key upcoming events in COPD
LIST OF TABLES
9 Table 1: Modified British Medical Research Council (mMRC) Questionnaire
10 Table 2: COPD Assessment Test (CAT)
11 Table 3: COPD assessment, by spirometric grade
12 Table 4: The “ABCD” assessment tool
13 Table 5: Inhaled bronchodilators for COPD, by class
14 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
50 Table 10: Historical global sales, by drug ($m), 2016–20
52 Table 11: Forecasted global sales, by drug ($m), 2021–25
54 Table 12: Trelegy Ellipta for COPD (August 31, 2020)
55 Table 13: Trelegy Ellipta for COPD (August 28, 2020)
56 Table 14: Breztri Aerosphere for COPD (June 24, 2020)
58 Table 15: RPL554 (Inhaled) for COPD (March 31, 2020)
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