The sponsor should provide an assurance that the The sponsor has now provided copies of the This is acceptable. Targeted Data questionnaires for all the specified Targeted Data questionnaires for the important potential risks will be submitted to the TGA important identified risks: heart ‘Increased when they become available. Consequently these rate and tachycardia’ & ‘Hypersensitivity should be included in the RMP and/or the ASA when reactions’; the important potential risks: ‘QT these documents are next updated. prolongation’, blood pressure’ & ‘Increased toxicity’; and the important ‘Embryo-fetal missing information: ‘Decreased lymphocytes’ according to the update of the EU-RMP. The sponsor should provide compelling justification as The sponsor has now added a planned This is acceptable, although it is suggested to why the long-term observational studies required by safety study (PASS) to address Sections of the EU-RMP be reworked to the US FDA as post-marketing commitments have not cardiovascular safety, especially in elderly provide the required information in relation been included in the PP. Alternatively, if the sponsor patients, in the PP of the updated AU-RMP to the planned PASS, particularly in regard decides to include these studies within the PP, the and EU-RMP. to reporting milestones, when this relevant sections of the RMP and/or the ASA will need document is next updated. to be updated accordingly and at least draft protocols for these studies should be submitted to the TGA for review. The ASA refers to routine pharmacovigilance activities The sponsor has now changed the wording This is acceptable. rather than routine risk minimisation activities. in Section 3 of the ASA. Nevertheless the sponsor’s conclusion that no additional risk minimisation activities are needed is consistent with assessment of the US FDA and it is agreed the specified ongoing safety concerns would not appear to warrant additional risk minimisation activities.
The sponsor should provide an assurance that the Targeted Data questionnaires for all the specified important potential risks will be submitted to the TGA when they become available. Consequently these should be included in the RMP and/or the ASA when these documents are next updated. The sponsor has now provided copies of the Targeted Data questionnaires for the important identified risks: ‘Increased heart rate and tachycardia’ & ‘Hypersensitivity reactions’; the important potential risks: ‘QT prolongation’, ‘Increased blood pressure’ & ‘Embryo-fetal toxicity’; and the important missing information: ‘Decreased lymphocytes’ according to the update of the EU-RMP. This is acceptable. The sponsor should provide compelling justification as to why the long-term observational studies required by the US FDA as post-marketing commitments have not been included in the PP. Alternatively, if the sponsor decides to include these studies within the PP, the relevant sections of the RMP and/or the ASA will need to be updated accordingly and at least draft protocols for these studies should be submitted to the TGA for review. The sponsor has now added a planned safety study (PASS) to address cardiovascular safety, especially in elderly patients, in the PP of the updated AU-RMP and EU-RMP. This is acceptable, although it is suggested Sections of the EU-RMP be reworked to provide the required information in relation to the planned PASS, particularly in regard to reporting milestones, when this document is next updated. The ASA refers to routine pharmacovigilance activities rather than routine risk minimisation activities. Nevertheless the sponsor’s conclusion that no additional risk minimisation activities are needed is consistent with assessment of the US FDA and it is agreed the specified ongoing safety concerns would not appear to warrant additional risk minimisation activities. The sponsor has now changed the wording in Section 3 of the ASA. This is acceptable.
auspar-mirabegron-140109.docx