Otezla
Publisher: Datamonitor Healthcare
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DRUG OVERVIEW
Otezla (apremilast; Celgene) is a novel small molecule phosphodiesterase 4 (PDE4) inhibitor that has been shown to modulate the production of pro-inflammatory mediators including tumor necrosis factor alpha, interleukin (IL)-2, IL-17, IL-23, interferon-gamma, leukotrienes, and nitric oxide synthase.
Otezla first gained approval from the US Food and Drug Administration for the treatment of adult patients with active psoriatic arthritis in March 2014, and for the treatment of patients with moderate to severe plaque psoriasis in September 2014. The drug received subsequent EU approval for the two indications in January 2015.
TABLE OF CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Otezla : Axial spondyloarthritis (axSpA)
10 Otezla : Psoriatic arthritis (PsA)
22 Otezla : Psoriasis
LIST OF FIGURES
17 Figure 1: Otezla for psoriatic arthritis – SWOT analysis
18 Figure 2: Datamonitor Healthcare’s drug assessment summary of Otezla for psoriatic arthritis
19 Figure 3: Datamonitor Healthcare’s drug assessment summary of Otezla for psoriatic arthritis
29 Figure 4: Otezla for psoriasis – SWOT analysis
30 Figure 5: Datamonitor Healthcare’s drug assessment summary of Otezla in psoriasis
31 Figure 6: Datamonitor Healthcare’s drug assessment summary of Otezla in psoriasis
LIST OF TABLES
6 Table 1: Otezla drug profile
8 Table 2: Otezla Phase III data in axial spondyloarthritis
11 Table 3: Otezla drug profile
13 Table 4: Otezla pivotal trial data in psoriatic arthritis
16 Table 5: Otezla’s late-phase trial data in psoriatic arthritis
23 Table 6: Otezla drug profile
25 Table 7: Otezla pivotal trial data in psoriasis
26 Table 8: Pooled exposure-adjusted incidence rates from the ESTEEM 1 and ESTEEM 2 trials of Otezla in psoriasis
27 Table 9: Otezla late-phase trial data in psoriasis
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