information should be Efficacy and safety of Rixubis There is a high incidence of assigned as in these patients is not HIV in the target appropriate, and as expected to differ from other population. The sponsor specified by the RMP patients. states in the RMP that up to evaluator. 10% of haemophilia Therefore, Baxter proposes patients are HIV positive. not to include safety and efficacy in patients who are The RMP evaluator HIV positive or maintains the opinion that immunocompromised as this patient population important missing should be included as information within the RMP. missing information in the 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 Patients with hepatic disease It is noted that a statement the sponsor adds the were included in clinical is included in the Clinical unknown safety and studies with Rixubis. Patients Trials section of the PI efficacy for patients with a medical history of stating that this patient with liver disease as hepatitis (excluding those population has been missing information. with active disease) were excluded from participation Risk minimisation and included in clinical studies. in clinical trials. It is pharmacovigilance Patients with a medical understood that Baxter activities to address history of hepatitis or active does not believe that there this missing hepatitis with ALT and/or is a safety concern with this information should be AST not exceeding five times patient population using the assigned as the upper limit of normal product. appropriate, and as were included in clinical However, the RMP specified by the RMP studies. In pivotal Study evaluator maintains the evaluator. 250901, 63/73 subjects opinion that this patient (86%) who received IP had a population should be medical history of hepatitis (A included as missing and/or B and/or C). Of which, information in the table of 38 had increased liver ongoing safety concerns of parameters (ALT and/or AST the RMP. Reporting of and/or ALP) at screening or safety related events in this at any time point during study patient population should participation. occur in every PSUR. Patients with active hepatitis would need to be monitored more closely than other patients. The Australian PI reflects that patients with severe chronic liver disease (as evidenced by an INR > 1.4) were excluded from pivotal Study 250901. In addition, patients with hepatic disease are discussed within the context of
information should be assigned as appropriate, and as specified by the RMP evaluator. Efficacy and safety of Rixubis in these patients is not expected to differ from other patients. Therefore, Baxter proposes not to include safety and efficacy in patients who are HIV positive or immunocompromised as important missing information within the RMP. There is a high incidence of HIV in the target population. The sponsor states in the RMP that up to 10% of haemophilia patients are HIV positive. The RMP evaluator maintains the opinion that this patient population should be included as missing information in the 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 adds the unknown safety and efficacy for patients with liver 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 hepatic disease were included in clinical studies with Rixubis. Patients with a medical history of hepatitis (excluding those with active disease) were included in clinical studies. Patients with a medical history of hepatitis or active hepatitis with ALT and/or AST not exceeding five times the upper limit of normal were included in clinical studies. In pivotal Study 250901, 63/73 subjects (86%) who received IP had a medical history of hepatitis (A and/or B and/or C). Of which, 38 had increased liver parameters (ALT and/or AST and/or ALP) at screening or at any time point during study participation. Patients with active hepatitis would need to be monitored more closely than other patients. The Australian PI reflects that patients with severe chronic liver disease (as evidenced by an INR > 1.4) were excluded from pivotal Study 250901. In addition, patients with hepatic disease are discussed within the context of It is noted 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.
auspar-nonacog-gamma-140414.docx