Disease Analysis: Asthma
Author: Pammy Spicer
Publisher: Datamonitor Healthcare
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Defintion
Asthma is a chronic respiratory condition characterized by recurrent wheezing, coughing, and breathlessness, which occur in acute events known as exacerbations. Often triggered by factors such as exercise, allergen or irritant exposure, change in weather, or viral respiratory infections, these flare-ups can vary significantly in frequency and severity. Attacks consist of swelling of the lining of the bronchial tubes, which narrows airways and results in a reduction of airflow into and out of the lungs. Historically considered to be a single disease, asthma is now viewed more as an overlapping assemblage of individual phenotypes with various underlying pathophysiological processes leading to symptoms.
Latest key takeaways
- Datamonitor Healthcare estimates that in 2018, there were approximately 343.6 million prevalent cases of asthma in individuals aged up to 44 years worldwide, and forecasts that number to increase to 363.7 million prevalent cases by 2027.
- The GINA treatment strategy released in 2019 included an important change disrupting a fundamental practice in mild asthma management. Treatment with a short-acting beta 2 agonist (SABA) alone is no longer the preferred treatment for adults and adolescents with asthma. GINA 2021 now has two tracks, one with the preferred approach, using an inhaled corticosteroid (ICS)/formoterol as a single maintenance and reliever therapy (SMART), and a second allowing the more traditional approach using a SABA-based reliever with an ICS or an ICS/long-acting beta 2 agonist (LABA) combination. While short-acting bronchodilators may provide symptom relief for patients, they remain at risk for severe exacerbations. In late 2020, a similar update was made to the NAEPP guidelines.
- The majority of approved drugs in the asthma space are inhaled small molecules, while several newer approvals show a shift towards the development of injectable biologics.
- Since its launch as the first fixed-dose combination (FDC) of an ICS and a LABA, GlaxoSmithKline’s Advair has become a wellestablished gold-standard therapy in asthma. However, generic competition in Europe, and more recently in the US, marks the end of this successful history.
- Tezepelumab is a first-in-class human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin (TSLP), an epithelial cytokine. Results from the Phase III NAVIGATOR trial show that tezepelumab significantly reduced the annualized asthma exacerbation rate versus placebo over 52 weeks by 56% in the overall population, and by 41% in patients with a baseline blood eosinophil count of <300 cells/μL.
- The convenience of pipeline ICS/LABA/LAMA triple FDC therapies will only marginally increase the overall use of the LAMA drug class as physicians remain skeptical about the role of LAMAs in asthma.
- Key upcoming catalysts in asthma include topline results from Phase III studies for SABA/ICS combination PT027.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Patient segmentation
11 TREATMENT
11 Main pharmacological treatments are categorized as controllers or relievers
11 Treatment guidelines recommend step-up therapy
11 Reliever medications have traditionally consisted of SABAs
11 Controller medications have been dominated by ICSs and LABAs
12 Concomitant use of additional treatments may be considered
12 Add-on treatment for severe asthma has become highly personalized
12 New recommendations upend decades of routine asthma management
13 GINA 2021 now provides the preferred SMART-based track and the traditional SABA track
17 COVID-19 recommendations for asthma management
18 EPIDEMIOLOGY
18 Prevalence methodology
21 MARKETED DRUGS
28 PIPELINE DRUGS
36 KEY REGULATORY EVENTS
36 US FDA Grants Priority Review Status For Tezepelumab
36 Stada’s Thornton & Ross Rivals Seretide In UK
36 Lupin Gets Another First With Fostair
36 FDA Hands Lannett Goal Date On Generic Advair
37 Broad Population Sought For Amgen/AZ’s Tezepelumab
37 AZ/Amgen Fail In EU Fast-Track Bid For Tezepelumab
37 FDA Approves Xolair Prefilled Syringe For Self-Injection
37 Viatris Clears US Symbicort Hurdle But Loses Key Patent Fight To AstraZeneca
38 AstraZeneca & Amgen Seek EU Fast-Track For Severe Asthma Drug
38 13 New Drugs Pass Muster At The EMA
38 Hikma Launches Long-Awaited US Advair Rival
39 Teva Seeks To Simplify With Canadian Inhalers
39 Teva Completes ‘Digihaler Family’
39 Perrigo’s Albuterol Advantage Blunted By Recall
40 GSK’s Trelegy Ellipta Is First Triple Combination Approved For Asthma In the US
40 US Albuterol Market Hots Up With Lupin ProAir Approval
41 PROBABILITY OF SUCCESS
42 LICENSING AND ASSET ACQUISITION DEALS
42 Cipla Targets Global Respiratory Biosimilars With Kemwell JV
42 Vectura Opts For Tobacco Giant Philip Morris In Carlyle Takeover Tussle
42 Philip Morris Bid For Vectura Trumps Carlyle Takeover
43 Nuance Gets Greater China Rights To Verona’s Ensifentrine
43 Lupin’s US Advair Generic Plans Turn Awry As Celon Pact Nears End
43 Vectura Agrees £958m Takeover Following Hikma Advair Launch
43 Quercis Pharma Signs Worldwide License Agreement With Western New England University
44 China And US Added to Amneal-Iconovo Symbicort Alliance
44 Vectura Reaps Value From Pan-JAK Inhibitor For Severe Asthma
44 Allergy Therapeutics Takes First Steps Into Broader Vaccine Field
46 CLINICAL TRIAL LANDSCAPE
47 Sponsors by status
48 Sponsors by phase
49 Recent events
52 DRUG ASSESSMENT MODEL
52 ICSs
52 ICS/LABAs
53 ICS/LABA/LAMAs
54 Other oral classes
54 Biologics
56 MARKET DYNAMICS
57 FUTURE TRENDS
57 High biologic prices will translate to high revenues, despite restricted prescribing
57 The ICS/LABA class will remain dominant by patient share, as first-generation products lose share to follow-on products and generics
57 Skepticism regarding the role of LAMAs in asthma may blunt uptake of triple therapies
59 CONSENSUS FORECASTS
64 RECENT EVENTS AND ANALYST OPINION
64 PT027 for Asthma (September 9, 2021)
64 Dexpramipexole for Asthma (May 17, 2021)
66 Bemrist Breezhaler for Asthma (March 1, 2021)
66 Dupixent for Asthma (March 1, 2021)
68 Dupixent for Asthma (March 1, 2021)
69 Dupixent for Asthma (March 1, 2021)
70 Fasenra for Asthma (March 1, 2021)
71 Fasenra for Asthma (March 1, 2021)
73 Nucala Lyophilized Powder Formulation for Asthma (March 1, 2021)
74 Tezepelumab for Asthma (March 1, 2021)
76 Trelegy Ellipta for Asthma (March 1, 2021)
77 Zimbus Breezhaler for Asthma (March 1, 2021)
78 Tezepelumab for Asthma (February 26, 2021)
79 Tezepelumab for Asthma (December 22, 2020)
81 Tezepelumab for Asthma (November 10, 2020)
83 TD-8236 for Asthma (November 5, 2020)
84 GB001 for Asthma (October 13, 2020)
86 KEY UPCOMING EVENTS
87 KEY OPINION LEADER INSIGHTS
88 BIBLIOGRAPHY
89 APPENDIX
LIST OF FIGURES
20 Figure 1: Trends in prevalent cases of asthma, 2018–27
28 Figure 2: Overview of pipeline drugs for asthma in the US
28 Figure 3: Pipeline drugs for asthma, by company
29 Figure 4: Pipeline drugs for asthma, by drug type
29 Figure 5: Pipeline drugs for asthma, by classification
41 Figure 6: Probability of success in the asthma pipeline
46 Figure 7: Clinical trials in asthma
46 Figure 8: Top 10 drugs for clinical trials in asthma
47 Figure 9: Top 10 companies for clinical trials in asthma
47 Figure 10: Trial locations in asthma
48 Figure 11: Asthma trials status
49 Figure 12: Asthma trials sponsors, by phase
52 Figure 13: Datamonitor Healthcare’s drug assessment summary for asthma
56 Figure 14: Market dynamics in asthma
57 Figure 15: Future trends in asthma
68 Figure 16: Dupixent for Asthma (March 1, 2021): Phase III – LIBERTY ASTHMA TRAVERSE (Long-Term Follow-Up)
79 Figure 17: Tezepelumab for Asthma (February 26, 2021): Phase III – NAVIGATOR
81 Figure 18: Tezepelumab for Asthma (December 22, 2020): Phase III – SOURCE
83 Figure 19: Tezepelumab for Asthma (November 10, 2020): Phase III – NAVIGATOR
85 Figure 20: GB001 for Asthma (October 13, 2020): Phase IIb – LEDA
86 Figure 21: Key upcoming events in asthma
LIST OF TABLES
10 Table 1: Patient severity in asthma
14 Table 2: GINA treatment recommendations for asthma: Track 1
15 Table 3: GINA treatment recommendations for asthma: Track 2
16 Table 4: NAEPP EPR-3 Guidelines and Focused Update
19 Table 5: Prevalent cases of asthma, 2018–27
22 Table 6: Marketed drugs for asthma
30 Table 7: Pipeline drugs for asthma in the US
60 Table 8: Historical global sales, by drug ($m), 2016–20
62 Table 9: Forecasted global sales, by drug ($m), 2021–25
64 Table 10: PT027 for Asthma (September 9, 2021)
65 Table 11: Dexpramipexole for Asthma (May 17, 2021)
66 Table 12: Bemrist Breezhaler for Asthma (March 1, 2021)
67 Table 13: Dupixent for Asthma (March 1, 2021)
68 Table 14: Dupixent for Asthma (March 1, 2021)
70 Table 15: Dupixent for Asthma (March 1, 2021)
71 Table 16: Fasenra for Asthma (March 1, 2021)
72 Table 17: Fasenra for Asthma (March 1, 2021)
73 Table 18: Nucala Lyophilized Powder Formulation for Asthma (March 1, 2021)
75 Table 19: Tezepelumab for Asthma (March 1, 2021)
76 Table 20: Trelegy Ellipta for Asthma (March 1, 2021)
77 Table 21: Zimbus Breezhaler for Asthma (March 1, 2021)
78 Table 22: Tezepelumab for Asthma (February 26, 2021)
80 Table 23: Tezepelumab for Asthma (December 22, 2020)
82 Table 24: Tezepelumab for Asthma (November 10, 2020)
83 Table 25: TD-8236 for Asthma (November 5, 2020)
84 Table 26: GB001 for Asthma (October 13, 2020)
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