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Market Spotlight: Systemic Lupus Erythematosus (SLE)

  • ID: 4846156
  • Report
  • January 2020
  • Region: Global
  • 52 Pages
  • Datamonitor Healthcare
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This Market Spotlight report covers the SLE market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, patent information, epidemiology information, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways
  • The approved drugs in the systemic lupus erythematosus (SLE) space target B-cell activating factor, glucocorticoid receptor, corticotropin releasing factor, and corticotropin releasing hormone. These drugs are administered via the subcutaneous, intravenous, intramuscular, and oral routes.
  • The majority of industry-sponsored drugs in active clinical development for SLE are in Phase II. Therapies in development for SLE focus on a wide variety of targets. The majority of pipeline drugs are administered via the subcutaneous route, with the remainder being intravenous, oral, and intramuscular formulations.
  • High-impact upcoming events for drugs in the SLE space comprise topline Phase II trial results for evobrutinib and lenabasum, topline Phase IIa trial results for RSLV-132, topline Phase Ib/IIa trial results for PRV-3279, topline Phase III trial results for Benlysta, and an expected patent expiration for INV103.
  • The overall likelihood of approval of a Phase I SLE asset is 5.2%, and the average probability a drug advances from Phase III is 44.4%. Drugs, on average, take 9.6 years from Phase I to approval, compared to 9.0 years in the overall autoimmune/immunology space.
  • There have been 18 licensing and asset acquisition deals involving SLE drugs during 2014-19. The largest deal during the period was the $690m exclusive collaboration and license agreement signed in 2015 between Eli Lilly and Hanmi Pharmaceutical to develop and commercialize HM71224 for potential treatment of rheumatoid arthritis, lupus, lupus nephritis, Sjögren's syndrome, and other related conditions.
  • The distribution of clinical trials across Phase I-IV indicates that the majority of trials for SLE have been in the early and midphases of development, with 68% of trials in Phase I-II, and 32% in Phase III-IV.
  • The US has a substantial lead in the number of SLE clinical trials globally. Germany leads the major EU markets, while South Korea has the top spot in Asia.
  • Clinical trial activity in the SLE space is dominated by completed trials. GlaxoSmithKline has the highest number of completed clinical trials for SLE, with 28 trials.
  • GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for SLE, followed by AstraZeneca
Note: Product cover images may vary from those shown
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Contents

Overview

Key Takeaways

Disease Background
  • Disease definition
  • Symptoms
  • Patient subtypes
  • Risk factors
  • Diagnosis
Treatment
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) and pain relievers
  • Corticosteroids
  • Antimalarial drugs
  • Immunosuppressive agents
  • Anticoagulants
  • Monoclonal antibodies
  • Repository corticotropin injection
Epidemiology

Marketed Drugs

Pipeline Drugs

Recent Events and Analyst Opinion
  • BIIB059 for SLE (December 3, 2019)
  • Multiple Drugs for SLE (October 24, 2019)
  • Anifrolumab for SLE (August 29, 2019)
  • CC-11050 for SLE (August 26, 2019)
  • Lupuzor for SLE (June 28, 2019)
  • IFNa Kinoid for SLE (April 6, 2019)
  • Dapirolizumab Pegol for SLE (October 23, 2018)
  • XmAb5871 for SLE (October 5, 2018)
  • Anifrolumab for SLE (August 31, 2018)
  • IFNa Kinoid for SLE (July 3, 2018)
  • Olumiant for SLE (June 13, 2018)
Key Upcoming Events

Key Regulatory Events
  • Benlysta Becomes First Approved Treatment For Pediatric Lupus
Probability of Success

Licensing and Asset Acquisition Deals

Parent Patents

Revenue Opportunity

Clinical Trial Landscape
  • Sponsors by status
  • Sponsors by phase
  • Recent events
Bibliograpy
  • Prescription information
Appendix

List of Figures
Figure 1: Overview of pipeline drugs for SLE in the US
Figure 2: Pipeline drugs for SLE, by company
Figure 3: Pipeline drugs for SLE, by drug type
Figure 4: Pipeline drugs for SLE, by classification
Figure 5: BIIB059 for SLE (December 3 2019): Phase II - LILAC
Figure 6: Anifrolumab for SLE (August 29, 2019): Phase III - TULIP SLE 2 (IV)
Figure 7: Dapirolizumab Pegol for SLE (October 23, 2018): Phase IIb - SL0023
Figure 8: XmAb5871 for SLE (October 5, 2018): Phase II - XmAb5871-04
Figure 9: Anifrolumab for SLE (August 31, 2018): Phase III - TULIP SLE 1 (IV)
Figure 10: IFNa Kinoid for SLE (July 3, 2018): Phase IIb - IFN-K-002
Figure 11: Olumiant for SLE (June 13, 2018): Phase II - 16270
Figure 12: Key upcoming events in SLE
Figure 13: Probability of success in the SLE pipeline
Figure 14: Licensing and asset acquisition deals in SLE, 2014–19
Figure 15: Parent patents in SLE
Figure 16: Clinical trials in SLE
Figure 17: Top 10 drugs for clinical trials in SLE
Figure 18: Top 10 companies for clinical trials in SLE
Figure 19: Trial locations in SLE
Figure 20: SLE trials status
Figure 21: SLE trials sponsors, by phase

List of Tables
Table 1: Marketed drugs for SLE
Table 2: Pipeline drugs for SLE in the US
Table 3: BIIB059 for SLE (December 3, 2019)
Table 4: Multiple Drugs for SLE (October 24, 2019)
Table 5: Anifrolumab for SLE (August 29, 2019)
Table 6: CC-11050 for SLE (August 26, 2019)
Table 7: Lupuzor for SLE (June 28, 2019)
Table 8: IFNa Kinoid for SLE (April 6, 2019)
Table 9: Dapirolizumab Pegol for SLE (October 23, 2018)
Table 10: XmAb5871 for SLE (October 5, 2018)
Table 11: Anifrolumab for SLE (August 31, 2018)
Table 12: IFNa Kinoid for SLE (July 3, 2018)
Table 13: Olumiant for SLE (June 13, 2018)
Table 14: Historical global sales, by drug ($m), 2014–18
Table 15: Forecasted global sales, by drug ($m), 2019–23
Note: Product cover images may vary from those shown
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