For the missing information The sponsor states: This is acceptable. related to safety information in the would like to “AbbVie treatment of children < 6 years of point out that this age for pedCD, and long term information has been safety information in the captured in version 4.0 of treatment of children aged 6 years the ASA, which was to < 18 years with pedERA’, Table submitted recently in 3: of Ongoing and PM–2015–01149–1–3. ‘Overview Planned Pharmacovigilance Please refer to Table 3, Actions’ of the ASA should be Overview of Ongoing and amended to include details of Planned Study M11328 to be consistent Pharmacovigilance with Table 100: Actions, on page 46 (of ‘Required Additional Pharmacovigilance 79)”. Activities’ of the EU–RMP. For clarity and as per the ASA The sponsor states: In the instance Table 5 template, as found on the TGA would like to should be renamed and ‘AbbVie website as of 4 May 2015, the point out that this corrected to of ‘Summary sponsor should include a table information has been the Risk Management Plan briefly summarising the captured in version 4.0 of in Australia’. Secondly it is pharmacovigilance and risk the ASA, which was apparent that the specified minimisation activities proposed submitted recently in missing information in Table for Australia in a revised ASA. Please 4: of the Risk ‘Summary refer to Table 5, Summary Minimisation Plan in of the Risk Minimisation Australia’ and Table 5 of the Plan in Australia, on updated ASA has been pages 58 (of 79)’. significantly rationalised, –68 including the deletion of with renal or liver ‘Subjects impairment’, compared to what was previously accepted for Humira. It would appear the only justification offered for such change was ‘Missing information was updated’, which is considered to be inadequate. Consequently the sponsor should provide compelling justification for apparent changes to the missing information items previously accepted for Humira or alternatively reinstate these safety concerns, which need only be reflected in a revised ASA preferably before this application is approved.
For the missing information related to safety information in the treatment of children < 6 years of age for pedCD, and long term safety information in the treatment of children aged 6 years to < 18 years with pedERA’, Table 3: ‘Overview of Ongoing and Planned Pharmacovigilance Actions’ of the ASA should be amended to include details of Study M11328 to be consistent with Table 100: ‘Required Additional Pharmacovigilance Activities’ of the EU–RMP. The sponsor states: “AbbVie would like to point out that this information has been captured in version 4.0 of the ASA, which was submitted recently in PM–2015–01149–1–3. Please refer to Table 3, Overview of Ongoing and Planned Pharmacovigilance Actions, on page 46 (of 79)”. This is acceptable. For clarity and as per the ASA template, as found on the TGA website as of 4 May 2015, the sponsor should include a table briefly summarising the pharmacovigilance and risk minimisation activities proposed for Australia in a revised ASA. The sponsor states: ‘AbbVie would like to point out that this information has been captured in version 4.0 of the ASA, which was submitted recently in Please refer to Table 5, Summary of the Risk Minimisation Plan in Australia, on pages 58 –68 (of 79)’. In the instance Table 5 should be renamed and corrected to ‘Summary of the Risk Management Plan in Australia’. Secondly it is apparent that the specified missing information in Table 4: ‘Summary of the Risk Minimisation Plan in Australia’ and Table 5 of the updated ASA has been significantly rationalised, including the deletion of ‘Subjects with renal or liver impairment’, compared to what was previously accepted for Humira. It would appear the only justification offered for such change was ‘Missing information was updated’, which is considered to be inadequate. Consequently the sponsor should provide compelling justification for apparent changes to the missing information items previously accepted for Humira or alternatively reinstate these safety concerns, which need only be reflected in a revised ASA preferably before this application is approved.
auspar-adalimumab-rch-160712.docx