Table 7: Reconciliation of issues outlined in the RMP report Recommendation in RMP Sponsor’s response PMSB evaluation report evaluator comment Safety considerations may be There was no nonclinical The response raised by the nonclinical and evaluation relevant for this has been clinical evaluators through the application. consolidated request for further In the round Clinical information and/or the Nonclinical Evaluation Report issued 1 May and Clinical Evaluation Reports 2014, there are no new safety respectively. It is important to considerations raised by the ensure that the information clinical evaluator that would provided in response to these require further consideration in include a consideration of the the Risk Management Plan. relevance for the Risk Management Plan, 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 necessary to address the issue in the RMP. It is recommended that the in Revision has been made to the This is the EU-RMP providing details and ASA to the EU-RMP to provide considered milestones regarding the an update of the milestones of acceptable. ongoing/planned studies be the ongoing/planned studies. updated. Furthermore, the sponsor A commitment is provided that should submit the final PASS the final PASS protocol, and the protocol, and the final outcome of final outcome of the outcome the outcome Study BAY Study BAY 86-5321/16598 will for review. be submitted to the TGA for review when they become available. It is recommended that the The sponsor has considered the This is sponsor implements educational issues raised in the RMP considered materials for patients to accurately evaluation report and hereby acceptable. inform patients the frequency accepts the RMP However, it is of side effects associated with the recommendation to implement recommended use of Eylea. patient educational materials as that the final an additional risk minimisation version of the activity to inform patients about educational the frequency of side effects materials be associated with the use of Eylea. submitted to The ASA has been updated the TGA for accordingly and a draft content review. of the patient educational material for implementation in Australia is provided in the Appendix of the updated ASA. It is recommended that the The sponsor has considered the Pending the sponsor undertakes further risk issues raised in the RMP Delegate’s minimisation activities to prevent evaluation report and hereby approval this
Table 7: Reconciliation of issues outlined in the RMP report Recommendation in RMP evaluation report Sponsor’s response PMSB evaluator comment Safety considerations may be raised by the nonclinical and clinical evaluators through the consolidated request for further information and/or the Nonclinical and Clinical Evaluation Reports respectively. It is important to ensure that the information provided in response to these include a consideration of the relevance for the Risk Management Plan, 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 necessary to address the issue in the RMP. There was no nonclinical evaluation relevant for this application. In the round Clinical Evaluation Report issued 1 May 2014, there are no new safety considerations raised by the clinical evaluator that would require further consideration in the Risk Management Plan. The response has been It is recommended that the in the EU-RMP providing details and milestones regarding the ongoing/planned studies be updated. Furthermore, the sponsor should submit the final PASS protocol, and the final outcome of the outcome Study BAY for review. Revision has been made to the ASA to the EU-RMP to provide an update of the milestones of the ongoing/planned studies. A commitment is provided that the final PASS protocol, and the final outcome of the outcome Study BAY 86-5321/16598 will be submitted to the TGA for review when they become available. This is considered acceptable. It is recommended that the sponsor implements educational materials for patients to accurately inform patients the frequency of side effects associated with the use of Eylea. The sponsor has considered the issues raised in the RMP evaluation report and hereby accepts the RMP recommendation to implement patient educational materials as an additional risk minimisation activity to inform patients about the frequency of side effects associated with the use of Eylea. The ASA has been updated accordingly and a draft content of the patient educational material for implementation in Australia is provided in the Appendix of the updated ASA. This is considered acceptable. However, it is recommended that the final version of the educational materials be submitted to the TGA for review. It is recommended that the sponsor undertakes further risk minimisation activities to prevent The sponsor has considered the issues raised in the RMP evaluation report and hereby Pending the Delegate’s approval this
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