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Disease Analysis: Asthma

  • ID: 5086949
  • Report
  • February 2021
  • Region: Global
  • 83 pages
  • Pharma Intelligence
Definition

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
  • The publisher 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 recommended for adults and adolescents with asthma. While short-acting bronchodilators may provide symptom relief for patients, they remain at risk for severe exacerbations. In late 2020, a similar, but still distinct 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 inhaled corticosteroid (ICS) and a long-acting beta 2 agonist (LABA), GlaxoSmithKline’s Advair has become a well-established gold-standard therapy in asthma. However, generic competition in Europe, and more recently in the US, marks the end of this successful history.
  • Novartis has ended development of its asthma drug fevipiprant following data which showed that the once-daily pill was not effective.
  • The convenience of pipeline ICS/LABA/long-acting muscarinic antagonist (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.
Note: Product cover images may vary from those shown
OVERVIEW
  • Latest key takeaways
DISEASE BACKGROUND
  • Definition
  • Patient segmentation
TREATMENT
  • Main pharmacological treatments are categorized as controllers or relievers
  • Treatment guidelines recommend step-up therapy
  • Reliever medications have traditionally consisted of SABAs
  • Controller medications have been dominated by ICSs and LABAs
  • Concomitant use of additional treatments may be considered
  • Add-on treatment for severe asthma has become highly personalized
  • New recommendations upend decades of routine asthma management
  • COVID-19 recommendations for asthma management
EPIDEMIOLOGY
  • Prevalence methodology
MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS
13 New Drugs Pass Muster At The EMA
  • Hikma Launches Long-Awaited US Advair Rival
  • Teva Seeks To Simplify With Canadian Inhalers
  • Teva Completes ‘Digihaler Family’
  • Perrigo’s Albuterol Advantage Blunted By Recall
  • GSK’s Trelegy Ellipta Is First Triple Combination Approved For Asthma In the US
  • US Albuterol Market Hots Up With Lupin ProAir Approval
  • Aurobindo’s US Respiratory Filing Could Rival Teva’s Qvar
  • Genentech Seeks Self-Administration Option For Xolair
  • Teva Launches ProAir Dry Powder Digital Inhaler
  • Novartis Triple Combo Enerzair Gets EU OK For Asthma
  • Japan Nods For Enerzair And Atectura For Asthma
  • Cipla Files ANDA For Advair Rival
  • Mylan Launches Advair Rival In Canada
  • England’s NICE Says No To Sanofi’s Dupixent For Asthma
  • US FDA Orders Singulair Boxed Warning On Neuropsychiatric Events Despite ‘Limited’ Evidence
PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • Vectura Reaps Value From Pan-JAK Inhibitor For Severe Asthma
  • Allergy Therapeutics Takes First Steps Into Broader Vaccine Field
  • Lannett Makes Deal For Respirent’s Flovent Diskus Rival
  • Chiesi Gets Bayer To Co-Promote Respiratory Drugs In China
  • GSK Sells Lesser Consumer Brands With Little Fanfare As Part Of Major Plan For Global Lead
  • Yuhan Partners With GI Innovation On Next-Generation Allergy Treatment
  • Iconovo And Amneal Collaborate On Symbicort Rival
  • LEO Pays $40m For Novel Dermatitis, Asthma Candidate
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events
DRUG ASSESSMENT MODEL
  • ICSs
  • ICS/LABAs
  • ICS/LABA/LAMAs
  • Other oral classes
  • Biologics
MARKET DYNAMICS

FUTURE TRENDS
  • High biologic prices will translate to high revenues, despite restricted prescribing
The ICS/LABA class will remain dominant by patient share, as first-generation products lose share to follow-on products and generics
  • Skepticism regarding the role of LAMAs in asthma may blunt uptake of triple therapies
CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION
  • Tezepelumab for Asthma (December 22, 2020)
  • Tezepelumab for Asthma (November 10, 2020)
  • TD-8236 for Asthma (November 5, 2020)
  • GB001 for Asthma (October 13, 2020)
  • QAW039 for Asthma (December 16, 2019)
  • Seliforant for Asthma (December 2, 2019)
  • Masitinib for Asthma (November 7, 2019)
  • QAW039 for Asthma (October 22, 2019)
  • Atectura Breezhaler for Asthma (September 30, 2019)
  • Enerzair Breezhaler for Asthma (September 30, 2019)
  • Trimbow for Asthma (September 30, 2019)
KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

BIBLIOGRAPHY

APPENDIX

LIST OF FIGURES
Figure 1: Trends in prevalent cases of asthma, 2018–27
Figure 2: Overview of pipeline drugs for asthma in the US
Figure 3: Pipeline drugs for asthma, by company
Figure 4: Pipeline drugs for asthma, by drug type
Figure 5: Pipeline drugs for asthma, by classification
Figure 6: Probability of success in the asthma pipeline
Figure 7: Clinical trials in asthma
Figure 8: Top 10 drugs for clinical trials in asthma
Figure 9: Top 10 companies for clinical trials in asthma
Figure 10: Trial locations in asthma
Figure 11: Asthma trials status
Figure 12: Asthma trials sponsors, by phase
Figure 13: The publisher’s drug assessment summary for asthma
Figure 14: Market dynamics in asthma
Figure 15: Future trends in asthma
Figure 16: Tezepelumab for Asthma (December 22, 2020): Phase III - SOURCE
Figure 17: Tezepelumab for Asthma (November 10, 2020): Phase III - NAVIGATOR
Figure 18: GB001 for Asthma (October 13, 2020): Phase IIb - LEDA
Figure 19: QAW039 for Asthma (December 16, 2019): Phase III - LUSTER 1, Phase III - LUSTER 2
Figure 20: Seliforant for Asthma (December 2, 2019): Related Drug - Trial Data
Figure 21: Masitinib for Asthma (November 7, 2019): Phase III - AB07015
Figure 22: QAW039 for Asthma (October 22, 2019): Phase III - ZEAL-1, Phase III - ZEAL-2
Figure 23: Atectura Breezhaler for Asthma (September 30, 2019): Phase III - PALLADIUM
Figure 24: Enerzair Breezhaler for Asthma (September 30, 2019): Phase III - IRIDIUM (w/QMF149)
Figure 25: Trimbow for Asthma (September 30, 2019): Phase III - TRIGGER, Phase III - TRIMARAN
Figure 26: Key upcoming events in asthma

LIST OF TABLES
Table 1: Patient severity in asthma
Table 2: GINA treatment recommendations for asthma
Table 3: NAEPP EPR-3 Guidelines and Focused Update
Table 4: Prevalent cases of asthma, 2018–27
Table 5: Marketed drugs for asthma
Table 6: Pipeline drugs for asthma in the US
Table 7: Historical global sales, by drug ($m), 2015–19
Table 8: Forecasted global sales, by drug ($m), 2021–25
Table 9: Tezepelumab for Asthma (December 22, 2020)
Table 10: Tezepelumab for Asthma (November 10, 2020)
Table 11: TD-8236 for Asthma (November 5, 2020)
Table 12: GB001 for Asthma (October 13, 2020)
Table 13: QAW039 for Asthma (December 16, 2019)
Table 14: Seliforant for Asthma (December 2, 2019)
Table 15: Masitinib for Asthma (November 7, 2019)
Table 16: QAW039 for Asthma (October 22, 2019)
Table 17: Atectura Breezhaler for Asthma (September 30, 2019)
Table 18: Enerzair Breezhaler for Asthma (September 30, 2019)
Table 19: Trimbow for Asthma (September 30, 2019)
Note: Product cover images may vary from those shown
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