thromboembolic events in the Australian PI. Therefore, Baxter proposes not to include safety and efficacy in patients with hepatic disease as important missing information within the RMP. It is recommended that Patients with renal disease It is that a statement is the sponsor adds the were excluded from clinical included in the Clinical unknown safety and populations for Rixubis Trials section of the PI efficacy for patients and are routinely excluded stating that this patient with renal disease as from clinical trial populations. population has been missing information. excluded from participation Baxter does not believe this Risk minimisation and in clinical trials. It is constitutes Important Missing pharmacovigilance understood that Baxter Information for inclusion in activities to address does not believe that there the RMP. As the haemophilia this missing is a safety concern with this B population ages, there may information should be patient population using the be an increased incidence of assigned as product. renal disease. However, it is appropriate, and as not currently considered a However, the RMP specified by the RMP leading co-morbidity in this evaluator maintains the evaluator. population. opinion that this patient population should be Therefore, Baxter proposes included as missing not to include the safety and information in the table of efficacy in patients with renal ongoing safety concerns of disease as important missing the RMP. Reporting of information within the RMP. safety related events in this patient population should occur in every PSUR. It is recommended that Baxter will endeavour to The sponsor should note the sponsor submits submit final or interim study that relevant study results final or interim study reports (resulting from the from studies, referenced in reports, resulting from ongoing clinical trials) to the the RMP, can be submitted the ongoing clinical TGA. However, as there is no to the RMP coordinator. trials, to the TGA at the existing process in TGA that Such a submission should same time as reports allows sponsors to submit include a cover letter are submitted to other study reports independently summarising the study regulatory agencies. of a major variation, the results and any impact the timing of these submissions results may have on the may not be in sync with that RMP. of other regulatory agencies. Please submit to the RMP coordinator e-mail address: VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations:
thromboembolic events in the Australian PI. Therefore, Baxter proposes not to include safety and efficacy in patients with hepatic disease as important missing information within the RMP. It is recommended that the sponsor adds the unknown safety and efficacy for patients with renal disease as missing information. Risk minimisation and pharmacovigilance activities to address this missing information should be assigned as appropriate, and as specified by the RMP evaluator. Patients with renal disease were excluded from clinical populations for Rixubis and are routinely excluded from clinical trial populations. Baxter does not believe this constitutes Important Missing Information for inclusion in the RMP. As the haemophilia B population ages, there may be an increased incidence of renal disease. However, it is not currently considered a leading co-morbidity in this population. Therefore, Baxter proposes not to include the safety and efficacy in patients with renal disease as important missing information within the RMP. It is that a statement is included in the Clinical Trials section of the PI stating that this patient population has been excluded from participation in clinical trials. It is understood that Baxter does not believe that there is a safety concern with this patient population using the product. However, the RMP evaluator maintains the opinion that this patient population should be included as missing information in the table of ongoing safety concerns of the RMP. Reporting of safety related events in this patient population should occur in every PSUR. It is recommended that the sponsor submits final or interim study reports, resulting from the ongoing clinical trials, to the TGA at the same time as reports are submitted to other regulatory agencies. Baxter will endeavour to submit final or interim study reports (resulting from the ongoing clinical trials) to the TGA. However, as there is no existing process in TGA that allows sponsors to submit study reports independently of a major variation, the timing of these submissions may not be in sync with that of other regulatory agencies. The sponsor should note that relevant study results from studies, referenced in the RMP, can be submitted to the RMP coordinator. Such a submission should include a cover letter summarising the study results and any impact the results may have on the RMP. Please submit to the RMP coordinator e-mail address: VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations:
auspar-nonacog-gamma-140414.docx