Drug Overview
Cosentyx (secukinumab; Novartis) is a fully human monoclonal antibody which acts by neutralizing interleukin (IL)-17A. IL-17A is a pro-inflammatory cytokine secreted by activated T cells. It is indicated for the treatment of plaque psoriasis, psoriatic arthritis (PsA), and axial spondyloarthritis. Cosentyx was approved by the EU for the treatment of active ankylosing spondylitis (AS) in November 2015. This was followed by the US Food and Drug Administration, which approved Cosentyx for the treatment of AS in January 2016. In December 2014, the Japanese Ministry of Health, Labour and Welfare approved Cosentyx for the treatment of psoriasis and PsA in adults who have failed to respond adequately to systemic therapies (except for biologics). This was the first regulatory approval for Cosentyx in the world, making the drug the first-in-class IL-17A inhibitor in Japan. Cosentyx received EU and US approvals for the treatment of PsA in November 2015 and January 2016, respectively.
TABLE OF CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Cosentyx : Axial spondyloarthritis (axSpA)
22 Cosentyx : Psoriatic arthritis (PsA)
34 Cosentyx : Psoriasis
LIST OF FIGURES
14 Figure 1: Cosentyx for axial spondyloarthritis – SWOT analysis
15 Figure 2: Datamonitor Healthcare’s drug assessment summary of Cosentyx in axial spondyloarthritis
16 Figure 3: Datamonitor Healthcare’s drug assessment summary of Cosentyx in axial spondyloarthritis
19 Figure 4: Cosentyx sales for axial spondyloarthritis across the US, Japan, and five major EU markets, by country, 2016–25
29 Figure 5: Cosentyx for psoriatic arthritis – SWOT analysis
30 Figure 6: Datamonitor Healthcare’s drug assessment summary of Cosentyx for psoriatic arthritis
31 Figure 7: Datamonitor Healthcare’s drug assessment summary of Cosentyx for psoriatic arthritis
48 Figure 8: Cosentyx for psoriasis – SWOT analysis
49 Figure 9: Datamonitor Healthcare’s drug assessment summary of Cosentyx in psoriasis
50 Figure 10: Datamonitor Healthcare’s drug assessment summary of Cosentyx in psoriasis
LIST OF TABLES
5 Table 1: Cosentyx drug profile
7 Table 2: Cosentyx pivotal trial data in axial spondyloarthritis
9 Table 3: Late-phase trials for Cosentyx in axial spondyloarthritis
12 Table 4: Ongoing late-phase trials for Cosentyx in axial spondyloarthritis
20 Table 5: Cosentyx sales for axial spondyloarthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
23 Table 6: Cosentyx drug profile
25 Table 7: Cosentyx pivotal trial data in psoriatic arthritis
28 Table 8: Cosentyx ongoing late-phase trials in psoriatic arthritis
35 Table 9: Cosentyx drug profile
37 Table 10: Cosentyx pivotal trial data in psoriasis
40 Table 11: Cosentyx late-phase trial data in psoriasis
43 Table 12: Cosentyx ongoing late-phase clinical trials in psoriasis