Product Information The approved Product Information (PI) current at the time this AusPAR was prepared can be as Attachment 1. For the most recent Product Information please refer to the TGA website at <>. II. Quality findings was no requirement for a quality evaluation in a submission of this type. III. Nonclinical findings There was no requirement for a nonclinical evaluation in a submission of this type. IV. Clinical findings A summary of the clinical findings is presented in this section. Further details of these clinical findings can be found in Attachment 2. Introduction ETN is a recombinant, humanized tumour necrosis factor (TNF) receptor fusion protein, which has high affinity binding to TNF and blocks its interaction with cell surface TNF receptors. Clinical rationale JIA encompasses a diverse group of arthritic conditions of unknown aetiology that begin before the sixteenth birthday, and persist for at least 6 weeks. It is one of the most physically disabling conditions of childhood, with prevalence in Australia of 0.3% according to the Australian Institute of Health and Welfare 2012 report. JIA is a heterogeneous disorder, and the subtypes have varying clinical and laboratory features that may reflect distinct immunopathogenic processes. The pathogenesis of each subtype is multifactorial and likely to be triggered by environmental stimuli in genetically susceptible individuals. JIA is a WHO endorsed, internationally accepted umbrella term that has replaced all previously used nomenclatures such as juvenile rheumatoid arthritis (JRA) and juvenile chronic arthritis (JCA). Further information is contained within the Clinical Evaluation Report (CER) at Attachment 2. Guidance The TGA has recommended review and consideration of one specific regulatory guideline pertaining to the requested extension of indication. The TGA has adopted the EU guideline CPMP/EWP/422/04 on Clinical Investigation of Medicinal Products for the “Guideline Treatment of Juvenile Idiopathic Arthritis” (effective 26 June 2009). The sponsor has recommended consideration of 2 related guidelines in reviewing this submission: Committee for Medicinal Products for Human Use (CHMP) guidelines on Clinical Trials in Small Populations (July 2006) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on Choice of Control Group in Clinical Trials (January 2001).
Product Information The approved Product Information (PI) current at the time this AusPAR was prepared can be as Attachment 1. For the most recent Product Information please refer to the TGA website at <>. II. Quality findings was no requirement for a quality evaluation in a submission of this type. III. Nonclinical findings There was no requirement for a nonclinical evaluation in a submission of this type. IV. Clinical findings A summary of the clinical findings is presented in this section. Further details of these clinical findings can be found in Attachment 2. Introduction ETN is a recombinant, humanized tumour necrosis factor (TNF) receptor fusion protein, which has high affinity binding to TNF and blocks its interaction with cell surface TNF receptors. Clinical rationale JIA encompasses a diverse group of arthritic conditions of unknown aetiology that begin before the sixteenth birthday, and persist for at least 6 weeks. It is one of the most physically disabling conditions of childhood, with prevalence in Australia of 0.3% according to the Australian Institute of Health and Welfare 2012 report. JIA is a heterogeneous disorder, and the subtypes have varying clinical and laboratory features that may reflect distinct immunopathogenic processes. The pathogenesis of each subtype is multifactorial and likely to be triggered by environmental stimuli in genetically susceptible individuals. JIA is a WHO endorsed, internationally accepted umbrella term that has replaced all previously used nomenclatures such as juvenile rheumatoid arthritis (JRA) and juvenile chronic arthritis (JCA). Further information is contained within the Clinical Evaluation Report (CER) at Attachment 2. Guidance The TGA has recommended review and consideration of one specific regulatory guideline pertaining to the requested extension of indication. The TGA has adopted the EU guideline CPMP/EWP/422/04 “Guideline on Clinical Investigation of Medicinal Products for the Treatment of Juvenile Idiopathic Arthritis” (effective 26 June 2009). The sponsor has recommended consideration of 2 related guidelines in reviewing this submission: Committee for Medicinal Products for Human Use (CHMP) guidelines on Clinical Trials in Small Populations (July 2006) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on Choice of Control Group in Clinical Trials (January 2001).
auspar-etanercept-140424.docx