pharmacovigilance guidelines evaluator’s request ‘routine ‘Australian system in Australia’ in the ASA: requirements and in an updated ASA is Activities are carried out recommendations for considered according to the TGA pharmacovigilance acceptable. guidelines responsibilities of sponsors of ‘Australian requirements and medicines’, version 1.2, dated 8 recommendations for August 2013 (see section 8.2). pharmacovigilance responsibilities of sponsors of medicines’, version 1.1, dated Dec-2012 (see section 8.2). 3.d) The sponsor describes in The sponsor regrets the oversight This is considered this table that additional and agrees to delete the additional acceptable. activities are conducted for risk minimization activities from Ischemic cardiac events, the of pharmacovigilance Ischemic cerebrovascular activities in next update to the events and Ischemic peripheral ASA. These activities have also vascular events. However, the been deleted from the activities listed are additional corresponding table of the EU risk minimisation activities, RMP version 9.0. not additional pharmacovigilance activities. Consequently, these activities should be deleted from this table in an updated version of the ASA (see section 8.2). 3.e) The sponsor describes The sponsor acknowledges the The sponsor’s that the potential risk of error and will remove reference to commitment to teratogenicity is addressed by this study from the potential risk implement the RMP an additional of teratogenicity in the next evaluator’s request pharmacovigilance This update to the ASA. in an updated RMP is study is an vivo interaction considered ‘in study of the effect of ponatinib acceptable. Please on oral contraceptives’. It also to point 2.9 appears that this study will in this table. evaluate the interaction of ponatinib and oral contraceptives and therefore, does not provide any information on the teratogenic potential of ponatinib. Consequently, it is recommended that this table be amended and reference of this study be removed from the potential risk of In addition, the ‘teratogenicity’. sponsor should add of ponatinib with ‘Interaction oral contraceptives’ as missing information in the table of ongoing safety concerns, and assign the study to this missing information (see section 8.2).
‘routine pharmacovigilance system in Australia’ in the ASA: Activities are carried out according to the TGA guidelines ‘Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines’, version 1.1, dated Dec-2012 (see section 8.2). guidelines ‘Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines’, version 1.2, dated 8 August 2013 (see section 8.2). evaluator’s request in an updated ASA is considered acceptable. 3.d) The sponsor describes in this table that additional activities are conducted for Ischemic cardiac events, Ischemic cerebrovascular events and Ischemic peripheral vascular events. However, the activities listed are additional risk minimisation activities, not additional pharmacovigilance activities. Consequently, these activities should be deleted from this table in an updated version of the ASA (see section 8.2). The sponsor regrets the oversight and agrees to delete the additional risk minimization activities from the of pharmacovigilance activities in next update to the ASA. These activities have also been deleted from the corresponding table of the EU RMP version 9.0. This is considered acceptable. 3.e) The sponsor describes that the potential risk of teratogenicity is addressed by an additional pharmacovigilance This study is an ‘in vivo interaction study of the effect of ponatinib on oral contraceptives’. It appears that this study will evaluate the interaction of ponatinib and oral contraceptives and therefore, does not provide any information on the teratogenic potential of ponatinib. Consequently, it is recommended that this table be amended and reference of this study be removed from the potential risk of ‘teratogenicity’. In addition, the sponsor should add ‘Interaction of ponatinib with oral contraceptives’ as missing information in the table of ongoing safety concerns, and assign the study to this missing information (see section 8.2). The sponsor acknowledges the error and will remove reference to this study from the potential risk of teratogenicity in the next update to the ASA. The sponsor’s commitment to implement the RMP evaluator’s request in an updated RMP is considered acceptable. Please also to point 2.9 in this table.
auspar-ponatinib-150416.docx