Although Siliq (brodalumab; AstraZeneca/Valeant/Leo Pharma/Kyowa Hakko Kirin) is approved for the treatment of psoriatic arthritis (PsA) in Japan, Datamonitor Healthcare does not expect the drug to be further developed in the US and EU due to concerns associated with its safety profile, which led to the suspension of its clinical development. Indeed, the events of suicidal ideation and behavior observed in Siliq’s development program led Amgen to terminate its participation in the co-development of the drug in 2015, and clinical trials for PsA have been suspended.
Siliq is a fully humanized monoclonal antibody that binds to the interleukin (IL)-17 receptor and blocks inflammatory signaling. The drug is approved for psoriasis in the US, Japan, and EU (AstraZeneca, 2017; Valeant, 2017). Brodalumab obtained regulatory approval for the treatment of PsA in Japan in July 2016, where it is marketed under the brand name Lumicef (Kyowa Hakko Kirin, 2016a), but its development for the treatment of PsA in the US and EU is in doubt following the suspension of the pivotal AMVISION-1 and AMVISION-2 studies in July 2015 (Biomedtracker, 2016; EMA, 2015; FDA, 2016).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Siliq : Psoriasis
19 brodalumab : Psoriatic arthritis
LIST OF FIGURES
11 Figure 1: Design of Phase II trial of Siliq
12 Figure 2: Siliq for psoriasis – SWOT analysis
13 Figure 3: Datamonitor Healthcare’s drug assessment summary of Siliq in psoriasis
14 Figure 4: Datamonitor Healthcare’s drug assessment summary of Siliq in psoriasis
22 Figure 5: Brodalumab for psoriatic arthritis – SWOT analysis
24 Figure 6: Datamonitor Healthcare’s drug assessment summary of brodalumab in psoriatic
24 Figure 7: Datamonitor Healthcare’s drug assessment summary of brodalumab in psoriatic
LIST OF TABLES
4 Table 1: Siliq drug profile
6 Table 2: Siliq pivotal trial data in psoriasis
9 Table 3: Siliq late-phase trial data in psoriasis
11 Table 4: Clinical efficacy results for a Phase II open-label extension study of Siliq in psoriasis,
12 Table 5: Results for Phase II trial of Siliq in psoriasis, 2012
19 Table 6: Brodalumab drug profile
20 Table 7: Phase III trials of brodalumab for psoriatic arthritis
21 Table 8: Brodalumab Phase II data in psoriatic arthritis
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