necessary to address the issue in the RMP. 2. The ongoing studies The sponsor makes no This response is are not considered to be specific response to this considered part of the planned recommendation, but unsatisfactory, as it is clinical studies in the states: ASA, has been expected that ‘The pharmacovigilance plan. updated to incorporate submission of Therefore the related the RMP evaluator’s studies in Australia study protocols have not recommendations.’ would be closely aligned been reviewed. However, the sponsor to the planned date for Nevertheless these has only amended this submission of the final studies will either table by stating for each report in the EU whether generate safety data that study: submission it is referred to in a ‘No will simply support the planned to TGA. Final Product Safety Update known safety profile of report available upon Report (PSUR) or the medicine or generate request.’ submitted in an data that will provoke application to amend the applications to amend Australian registration the Australian details. Therefore this registration details. issue remains Consequently the table outstanding and should in Section 5.2.1 of the be adequately ASA should be amended addressed, including any to state the anticipated updating of the dates for their anticipated dates, before submission in Australia, this application is rather than in the EU. approved. 3. The sponsor’s The sponsor makes no n/a conclusion that routine specific response to this risk minimisation recommendation. activities for all the specified ongoing safety concerns are sufficient remains similar to what was previously accepted for Xolair and at this time continues to be acceptable. 4. At this time the The sponsor makes no n/a sponsor’s handling of specific response to this the potential for recommendation. medication errors with Xolair using routine pharmacovigilance and risk minimisation activities continues to remain acceptable. 5. As per the (RMP) The sponsor no No tabular comparison Questions and Answers specific response to this identifying and (Version 1.3, October recommendation, but providing reasons for
necessary to address the issue in the RMP. 2. The ongoing studies are not considered to be part of the planned clinical studies in the pharmacovigilance plan. Therefore the related study protocols have not been reviewed. Nevertheless these studies will either generate safety data that will simply support the known safety profile of the medicine or generate data that will provoke applications to amend the Australian registration details. Consequently the table in Section 5.2.1 of the ASA should be amended to state the anticipated dates for their submission in Australia, rather than in the EU. The sponsor makes no specific response to this recommendation, but states: ‘The ASA, has been updated to incorporate the RMP evaluator’s recommendations.’ However, the sponsor has only amended this table by stating for each study: ‘No submission planned to TGA. Final report available upon request.’ This response is considered unsatisfactory, as it is expected that submission of studies in Australia would be closely aligned to the planned date for submission of the final report in the EU whether it is referred to in a Product Safety Update Report (PSUR) or submitted in an application to amend the Australian registration details. Therefore this issue remains outstanding and should be adequately addressed, including any updating of the anticipated dates, before this application is approved. 3. The sponsor’s conclusion that routine risk minimisation activities for all the specified ongoing safety concerns are sufficient remains similar to what was previously accepted for Xolair and at this time continues to be acceptable. The sponsor makes no specific response to this recommendation. n/a 4. At this time the sponsor’s handling of the potential for medication errors with Xolair using routine pharmacovigilance and risk minimisation activities continues to remain acceptable. The sponsor makes no specific response to this recommendation. n/a 5. As per the (RMP) Questions and Answers (Version 1.3, October The sponsor no specific response to this recommendation, but No tabular comparison identifying and providing reasons for
auspar-omalizumab-rch-150721.docx