rationalised, including the due to underlying deletion of with conditions, such as ‘Subjects renal or liver impairment’. diabetes, renal or It would appear the only liver failure, human justification offered for immunodeficiency such change is virus infection, and ‘Missing information was updated’, alcohol or illicit drug which is considered to be abuse or inadequate. Consequently medications (such the sponsor should provide as post cancer compelling justification for chemotherapy and apparent changes to the anti-rejection drugs missing information items for organ previously accepted for transplant), that Humira or alternatively may have increased reinstate these safety known risks of concerns, which need only infection or other be reflected in a revised unknown risks ASA. related to the condition or to the concomitant medications. The sponsor has also provided justification for other changes to missing information items. No justification for the The sponsor states: This is acceptable. deletion of additional risk like to However, the ‘AbbVie minimisation activities for point out that this omission of the the important identified information has been important identified risk: of captured in version risk: of ‘Reactivation ‘Reactivation hepatitis B’ has been 4.0 of the ASA, which hepatitis B’ as a key provided and it appear was submitted safety risk warranting safety messages relating to recently. Please refer a HCP and patient this safety concern are still to Table 3, Overview educational program included in the educational the sub-heading: of Ongoing and materials attached as Planned Minimisation ‘Risk appendices to the ASA. The Pharmacovigilance Program’ (page 56 of sponsor should correct the ASA) and the Actions, on page 46 these omissions by revising (of 79)’. omission of additional Table 4: of the risk minimisation ‘Summary Risk Minimisation Plan in activities for the Australia’ and Table 5 of the important identified ASA to reinstate additional risk: of ‘Reactivation risk minimisation activities hepatitis B’ from for the important identified Table 5: of ‘Summary risk: of the Risk Management ‘Reactivation hepatitis B’. Plan in Australia’ of the ASA should be corrected when this
rationalised, including the deletion of ‘Subjects with renal or liver impairment’. It would appear the only justification offered for such change is ‘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. due to underlying conditions, such as diabetes, renal or liver failure, human immunodeficiency virus infection, and alcohol or illicit drug abuse or medications (such as post cancer chemotherapy and anti-rejection drugs for organ transplant), that may have increased known risks of infection or other unknown risks related to the condition or to the concomitant medications. The sponsor has also provided justification for other changes to missing information items. No justification for the deletion of additional risk minimisation activities for the important identified risk: ‘Reactivation of hepatitis B’ has been provided and it appear safety messages relating to this safety concern are still included in the educational materials attached as appendices to the ASA. The sponsor should correct these omissions by revising Table 4: ‘Summary of the Risk Minimisation Plan in Australia’ and Table 5 of the ASA to reinstate additional risk minimisation activities for the important identified risk: ‘Reactivation of hepatitis B’. The sponsor states: ‘AbbVie like to point out that this information has been captured in version 4.0 of the ASA, which was submitted recently. Please refer to Table 3, Overview of Ongoing and Planned Pharmacovigilance Actions, on page 46 (of 79)’. This is acceptable. However, the omission of the important identified risk: ‘Reactivation of hepatitis B’ as a key safety risk warranting a HCP and patient educational program the sub-heading: ‘Risk Minimisation Program’ (page 56 of the ASA) and the omission of additional risk minimisation activities for the important identified risk: ‘Reactivation of hepatitis B’ from Table 5: ‘Summary of the Risk Management Plan in Australia’ of the ASA should be corrected when this
auspar-adalimumab-170320.docx