Orencia (abatacept; Bristol-Myers Squibb/Ono Pharmaceutical) is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte antigen-4, linked to the Fc portion of immunoglobulin G1. The molecule acts as a selective co-stimulation modulator with inhibitory activity on T lymphocytes.
Orencia received US Food and Drug Administration and European Medicines Agency approval for the treatment of rheumatoid arthritis (RA) in December 2005 and May 2007, respectively. In Japan, Orencia was approved for use in RA in July 2010. Orencia is indicated to reduce the signs and symptoms of moderately to severely active adult RA as either a monotherapy or in combination with disease-modifying antirheumatic drugs, other than tumor necrosis factor inhibitors.
Orencia is currently undergoing Phase III trials in psoriatic arthritis and lupus nephritis.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Orencia : Rheumatoid arthritis
LIST OF FIGURES
17 Figure 1: Orencia’s SWOT analysis in rheumatoid arthritis
18 Figure 2: Datamonitor Healthcare’s drug assessment summary of Orencia in rheumatoid
19 Figure 3: Datamonitor Healthcare’s drug assessment summary of Orencia in rheumatoid
LIST OF TABLES
4 Table 1: Orencia’s drug profile in rheumatoid arthritis
6 Table 2: Overview of pivotal trial data for IV Orencia in rheumatoid arthritis
11 Table 3: Overview of pivotal trial data for SC Orencia in rheumatoid arthritis
13 Table 4: Summary of data from the AMPLE Phase III head-to-head trial of Orencia versus
Humira in biologic-naïve rheumatoid arthritis patients
15 Table 5: Data from the Phase III AMPLE head-to-head trial of Orencia versus Humira in
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