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Otezla

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    Report

  • 35 Pages
  • May 2018
  • Region: Global
  • Citeline
  • ID: 4775239
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

OVERVIEW
Drug Overview
Product Profiles
Otezla : Axial spondyloarthritis (axSpA)
Otezla : Psoriatic arthritis (PsA)
Otezla : Psoriasis
LIST OF FIGURES
Figure 1: Otezla for psoriatic arthritis – SWOT analysis
Figure 2: The authors drug assessment summary of Otezla for psoriatic arthritis
Figure 3: The authors drug assessment summary of Otezla for psoriatic arthritis
Figure 4: Otezla for psoriasis – SWOT analysis
Figure 5: The authors drug assessment summary of Otezla in psoriasis
Figure 6: The authors drug assessment summary of Otezla in psoriasis
LIST OF TABLES
Table 1: Otezla drug profile
Table 2: Otezla Phase III data in axial spondyloarthritis
Table 3: Otezla drug profile
Table 4: Otezla pivotal trial data in psoriatic arthritis
Table 5: Otezla’s late-phase trial data in psoriatic arthritis
Table 6: Otezla drug profile
Table 7: Otezla pivotal trial data in psoriasis
Table 8: Pooled exposure-adjusted incidence rates from the ESTEEM 1 and ESTEEM 2 trials of Otezla in psoriasis
Table 9: Otezla late-phase trial data in psoriasis