data lock point 15 November 2014) + Australia Specific Annex (version 2, dated 29 December 2014). A summary of the changes made are shown in Table 18. Table 18: Summary of key changes made to CCRMP and ASA Summary of key changes between CCRMP (v 1)/ASA (v 1) and CCRMP (v 2)/ASA(v 2) Safety New important identified risk: interactions’ ‘Drug-drug specification New important potential risk: risk of hepatic ‘Increased adverse events in patients with severe impairment not receiving hemodialysis’ New missing information: who failed prior ‘Patients treatment with NS3 protease inhibitors’ Amended missing information: in liver transplant ‘Use patients’ has been changed to in pre-, peri-, and post-liver ‘Use transplant patients’. Routine pharmacovigilance is proposed for the newly added risks. activities Risk Routine risk minimisation (ie product labelling statements) is proposed for the newly added risks. minimisation activities ASA Changes have been made to the PI text proposed for Australia in response to TGA evaluation reports. Suggested wording for conditions of registration RMP Any changes to which the sponsor agreed become part of the risk management system, whether they are included in the currently available version of the RMP document or not included inadvertently or otherwise. The suggesting wording is: Implement Asunaprevir Company Core RMP (version 2, dated 22 December 2014, data lock point 15 November 2014) with Australia Specific Annex (version 2, dated 29 December 2014) and any future updates as a condition of registration. VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations: Quality Registration of the proposed asunaprevir 100mg soft gelatin capsules is ‘Sunvepra’ recommended with respect to quality and biopharmaceutic aspects. All issues raised during the initial evaluation of this application have been satisfactorily resolved. Nonclinical There are nonclinical objections to the registration of asunaprevir.
data lock point 15 November 2014) + Australia Specific Annex (version 2, dated 29 December 2014). A summary of the changes made are shown in Table 18. Table 18: Summary of key changes made to CCRMP and ASA Summary of key changes between CCRMP (v 1)/ASA (v 1) and CCRMP (v 2)/ASA(v 2) Safety specification New important identified risk: ‘Drug-drug interactions’ New important potential risk: ‘Increased risk of hepatic adverse events in patients with severe impairment not receiving hemodialysis’ New missing information: ‘Patients who failed prior treatment with NS3 protease inhibitors’ Amended missing information: ‘Use in liver transplant patients’ has been changed to ‘Use in pre-, peri-, and post-liver transplant patients’. activities Routine pharmacovigilance is proposed for the newly added risks. Risk minimisation activities Routine risk minimisation (ie product labelling statements) is proposed for the newly added risks. ASA Changes have been made to the PI text proposed for Australia in response to TGA evaluation reports. Suggested wording for conditions of registration RMP Any changes to which the sponsor agreed become part of the risk management system, whether they are included in the currently available version of the RMP document or not included inadvertently or otherwise. The suggesting wording is: Implement Asunaprevir Company Core RMP (version 2, dated 22 December 2014, data lock point 15 November 2014) with Australia Specific Annex (version 2, dated 29 December 2014) and any future updates as a condition of registration. VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations: Quality Registration of the proposed ‘Sunvepra’ asunaprevir 100mg soft gelatin capsules is recommended with respect to quality and biopharmaceutic aspects. All issues raised during the initial evaluation of this application have been satisfactorily resolved. Nonclinical There are nonclinical objections to the registration of asunaprevir.
auspar-asunaprevir-151214.docx