Market Spotlight: Systemic Lupus Erythematosus (SLE)

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Report
40 Pages
May 2021
Region: Global
Citeline
ID: 4846156

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, 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, with only one drug in the NDA/BLA phase.
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, anifrolumab, and dapirolizumab pegol; an expected patent expiration for INV103; and an estimated PDUFA date as well as expected CHMP filing results for anifrolumab.
The overall likelihood of approval of a Phase I SLE asset is 4.6%, and the average probability a drug advances from Phase III is 45.5%. Drugs, on average, take 10.7 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 69% of trials in Phase I–II, and 31% 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 30 trials.
GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for SLE, followed by AstraZeneca.

OVERVIEWKEY 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

EPIDEMIOLOGYMARKETED DRUGSPIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

Lenabasum for SLE (October 6, 2020)
BIIB059 for SLE (December 3, 2019)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

China Inc. Shines In Latest Batch Of Approvals
Aurinia Launches Its First Drug With Lupkynis Approval For Lupus Nephritis
GSK Eyes Benlysta Expansion With First US FDA Lupus Nephritis Approval
AZ Takes On Lupus With Anifrolumab BLA

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

Merck & Co. Buys Pandion, Building Out Capability In Autoimmune Disease
With $3bn Viela Acquisition, Horizon Builds A Pipeline
Merck KGaA Out-Licenses Troubled Atacicept To Vera
AbbVie Pays $60m To Option Alpine’s Lupus Candidate

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

Sponsors by status
Sponsors by phase

BIBLIOGRAPHYAPPENDIX

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: Lenabasum for SLE (October 6, 2020): Phase IIb - Pulmonary Exacerbations
Figure 6: BIIB059 for SLE (December 3, 2019): Phase II - LILAC
Figure 7: Key upcoming events in SLE
Figure 8: Probability of success in the SLE pipeline
Figure 9: Clinical trials in SLE
Figure 10: Top 10 drugs for clinical trials in SLE
Figure 11: Top 10 companies for clinical trials in SLE
Figure 12: Trial locations in SLE
Figure 13: SLE trials status
Figure 14: 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: Lenabasum for SLE (October 6, 2020)
Table 4: BIIB059 for SLE (December 3, 2019)
Table 5: Historical global sales, by drug ($m), 2016–20
Table 6: Forecasted global sales, by drug ($m), 2021–25

Table of Contents

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