provide detail about how and when the evaluation of these additional risk minimisation activities will be undertaken and reported to the TGA. 2. The sponsor’s approach to See Recommendation 1 See Recommendation 1 simply updating the existing additional risk minimisation materials for intravenous Actemra with the information, precautions and instructions for using the new SC presentation is only acceptable if TGA approval for unsupervised home use of the SC formulation is obtained. The PSPAB will be guided by the PMAB evaluation of the supporting clinical data as to whether additional risk minimisation activities are required for the important identified risk: hypersensitivity ‘Serious reactions’, as it relates to the subcutaneous presentation. 3. The sponsor should For the missing information: This is acceptable. provide justification for the patients’, the sponsor These issues remain ‘Paediatric following identified states: outstanding for the Australian PI section ‘The differences between the EU Paediatric Use has Delegate’s consideration. ‘Precautions’, and the proposed Australian been updated to include a routine risk minimisation statement on the absence of data activities, or alternatively with the subcutaneous include such information in formulation in subjects less than the Australian PI to enhance 18 old. The existing text on safe use of the SC the clinical data with presentation: intravenous ACTEMRA has been For the important updated to specify the ACTEMRA potential risk: formulation used in those the studies’. ‘Immunogenicity’, ASA states: AU PI For the other issues the sponsor ‘The does not include the EU states: justification for the ‘A SPC data on the rate of absence of this text in the formation of IgE Australian PI has been added to antibodies following TCZ the updated version of the SC’. Australian Specific Annex to the For the missing EU-RMP’. information: ‘Paediatric patients’, the ASA states: SPC includes a ‘The specific statement that the subcutaneous formulation has not been studied in children’. For the missing information: in ‘Safety
provide detail about how and when the evaluation of these additional risk minimisation activities will be undertaken and reported to the TGA. 2. The sponsor’s approach to simply updating the existing additional risk minimisation materials for intravenous Actemra with the information, precautions and instructions for using the new SC presentation is only acceptable if TGA approval for unsupervised home use of the SC formulation is obtained. The PSPAB will be guided by the PMAB evaluation of the supporting clinical data as to whether additional risk minimisation activities are required for the important identified risk: ‘Serious hypersensitivity reactions’, as it relates to the subcutaneous presentation. See Recommendation 1 See Recommendation 1 3. The sponsor should provide justification for the following identified differences between the EU and the proposed Australian routine risk minimisation activities, or alternatively include such information in the Australian PI to enhance safe use of the SC presentation: For the important potential risk: ‘Immunogenicity’, the ASA states: ‘The AU PI does not include the EU SPC data on the rate of formation of IgE antibodies following TCZ SC’. For the missing information: ‘Paediatric patients’, the ASA states: ‘The SPC includes a specific statement that the subcutaneous formulation has not been studied in children’. For the missing information: ‘Safety in For the missing information: ‘Paediatric patients’, the sponsor states: ‘The Australian PI section ‘Precautions’, Paediatric Use has been updated to include a statement on the absence of data with the subcutaneous formulation in subjects less than 18 old. The existing text on the clinical data with intravenous ACTEMRA has been updated to specify the ACTEMRA formulation used in those studies’. For the other issues the sponsor states: ‘A justification for the absence of this text in the Australian PI has been added to the updated version of the Australian Specific Annex to the EU-RMP’. This is acceptable. These issues remain outstanding for the Delegate’s consideration.
auspar-tocilizumab-rch-160929.docx