Throbocytopenia Important potential trial Aterial Thrombotic Events (ATEs) Malignant neoplasms (in paediatric patients 6 to 12 years old) Off label use Important missing information Pregnancy outcomes Pharmacovigilance plan The sponsor proposes routine pharmacovigilance activities to monitor all the specified ongoing safety concerns, including the use of a targeted follow up questionnaire/checklist for the important identified risks: reactions’ and ‘Anaphylaxis/anaphylactoid ‘Malignant neoplasms in adults and adolescents 12 years of age’ and the important potential risk: ≥ Thromboembolic Events (ATEs)’. ‘Arterial Risk minimisation activities The sponsor proposes that routine risk minimisation activities for all the specified ongoing safety concerns are sufficient. Reconciliation of issues outlined in the RMP report Table 9 summarises the PMSB’s first round evaluation of the RMP, the sponsor’s responses to issues raised by the PSMB and the PSMB’s evaluation of the sponsor’s responses. Table 9. Reconciliation of issues outlined in the RMP report Recommendation in Sponsor’s response PSMB evaluator’s RMP evaluation report comment 1. Safety considerations The sponsor makes no The clinical evaluator may be raised by the specific response to this did not raise any clinical evaluator recommendation, but additional safety through the TGA’s states: ASA, has considerations. ‘The consolidated request for been updated to information and/or the incorporate the RMP CER respectively. It is evaluator’s important to ensure that recommendations.’ the information provided in response to these include a consideration of the relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, the sponsor should provide information that is relevant and
Throbocytopenia Important potential Aterial Thrombotic Events (ATEs) Malignant neoplasms (in paediatric patients 6 to 12 years old) Off label use Important missing information Pregnancy outcomes Pharmacovigilance plan The sponsor proposes routine pharmacovigilance activities to monitor all the specified ongoing safety concerns, including the use of a targeted follow up questionnaire/checklist for the important identified risks: ‘Anaphylaxis/anaphylactoid reactions’ and ‘Malignant neoplasms in adults and adolescents ≥ 12 years of age’ and the important potential risk: ‘Arterial Thromboembolic Events (ATEs)’. Risk minimisation activities The sponsor proposes that routine risk minimisation activities for all the specified ongoing safety concerns are sufficient. Reconciliation of issues outlined in the RMP report Table 9 summarises the PMSB’s first round evaluation of the RMP, the sponsor’s responses to issues raised by the PSMB and the PSMB’s evaluation of the sponsor’s responses. Table 9. Reconciliation of issues outlined in the RMP report Recommendation in RMP evaluation report Sponsor’s response PSMB evaluator’s comment 1. Safety considerations may be raised by the clinical evaluator through the TGA’s consolidated request for information and/or the CER respectively. It is important to ensure that the information provided in response to these include a consideration of the relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, the sponsor should provide information that is relevant and The sponsor makes no specific response to this recommendation, but states: ‘The ASA, has been updated to incorporate the RMP evaluator’s recommendations.’ The clinical evaluator did not raise any additional safety considerations. trial
auspar-omalizumab-rch-150721.docx