Market Spotlight: Systemic Lupus Erythematosus (SLE)
Market Spotlight: Systemic Lupus Erythematosus (SLE)
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This Market Spotlight report covers the Systemic Lupus Erythematosus (SLE) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, epidemiology information, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
This Market Spotlight report covers the Systemic Lupus Erythematosus (SLE) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, 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, corticotropin releasing hormone, and interferon-alpha. 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 largest proportion 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 lenabasum, iscalimab, and BMS-986165; topline Phase IIb trial results for cenerimod; topline Phase III trial results for Benlysta, Olumiant, Saphnelo, and dapirolizumab pegol; an expected patent expiration for INV103; and estimated CHMP filing results for Saphnelo.
- The overall likelihood of approval of a Phase I SLE asset is 5.7%, and the average probability a drug advances from Phase III is 45.5%. Drugs, on average, take 10.8 years from Phase I to approval, compared to 9.4 years in the overall autoimmune/immunology space.
- 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 European 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 31 trials.
- GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for SLE, followed by AstraZeneca.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Disease definition
8 Symptoms
8 Patient subtypes
8 Risk factors
9 Diagnosis
10 TREATMENT
10 Nonsteroidal anti-inflammatory drugs (NSAIDs) and pain relievers
10 Corticosteroids
10 Antimalarial drugs
10 Immunosuppressive agents
11 Anticoagulants
11 Monoclonal antibodies
11 Repository corticotropin injection
12 EPIDEMIOLOGY
12 Summary
12 Americas
12 Europe
12 Asia
12 Oceania
13 Africa
14 MARKETED DRUGS
16 PIPELINE DRUGS
24 RECENT EVENTS AND ANALYST OPINION
24 Olumiant for SLE (September 1, 2021)
25 Lenabasum for SLE (October 6, 2020)
28 KEY UPCOMING EVENTS
29 KEY REGULATORY EVENTS
29 FDA Accepts ANI’s Refiled Cortophin Gel
29 AstraZeneca To Challenge GSK After Clinching Lupus Drug Approval
29 ANI Refiles Cortrophin After Talks With FDA
30 China Inc. Shines In Latest Batch Of Approvals
30 Aurinia Launches Its First Drug With Lupkynis Approval For Lupus Nephritis
30 GSK Eyes Benlysta Expansion With First US FDA Lupus Nephritis Approval
30 AZ Takes On Lupus With Anifrolumab BLA
32 PROBABILITY OF SUCCESS
33 LICENSING AND ASSET ACQUISITION DEALS
33 Merck & Co. Buys Pandion, Building Out Capability In Autoimmune Disease
33 With $3bn Viela Acquisition, Horizon Builds A Pipeline
33 Merck KGaA Out-Licenses Troubled Atacicept To Vera
35 REVENUE OPPORTUNITY
36 CLINICAL TRIAL LANDSCAPE
37 Sponsors by status
38 Sponsors by phase
39 Recent events
40 BIBLIOGRAPHY
41 APPENDIX
LIST OF FIGURES
16 Figure 1: Overview of pipeline drugs for SLE in the US
16 Figure 2: Pipeline drugs for SLE, by company
17 Figure 3: Pipeline drugs for SLE, by drug type
17 Figure 4: Pipeline drugs for SLE, by classification
27 Figure 5: Lenabasum for SLE (October 6, 2020): Phase IIb – Pulmonary Exacerbations
28 Figure 6: Key upcoming events in SLE
32 Figure 7: Probability of success in the SLE pipeline
36 Figure 8: Clinical trials in SLE
36 Figure 9: Top 10 drugs for clinical trials in SLE
37 Figure 10: Top 10 companies for clinical trials in SLE
37 Figure 11: Trial locations in SLE
38 Figure 12: SLE trials status
39 Figure 13: SLE trials sponsors, by phase
LIST OF TABLES
15 Table 1: Marketed drugs for SLE
18 Table 2: Pipeline drugs for SLE in the US
24 Table 3: Olumiant for SLE (September 1, 2021)
26 Table 4: Lenabasum for SLE (October 6, 2020)
35 Table 5: Historical global sales, by drug ($m), 2016–20
35 Table 6: Forecasted global sales, by drug ($m), 2021–25
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