evaluations performed in this study. In regard to the The sponsor notes the comment. The evaluator has proposed routine risk Any proposed changes will be noted the minimisation activities, it is made to the PI after the Delegates sponsor’s recommended to the overview. response. The Delegate that the PI be recommendation updated to include the on the PI following statement document in the elderly’ as men ‘Use remains, for >70 years remains missing consideration by information: the Delegate. on patients older than 70 ‘Data years are limited’. (As in the EU SmPC) Summary of recommendations It is considered that the sponsor’s response to the TGA has adequately addressed most of the issues identified in the RMP evaluation report. Additional recommendations are detailed below. Outstanding issues Issues in relation to the RMP The recommendation on the draft Product Information remains, awaiting consideration by the Delegate. Additional recommendations The evaluator supports the clinical evaluator’s comments. The sponsor has provided a justification as to why QT interval prolongation is not considered a safety concern for avanafil (see sponsor’s response to Recommendation 4 under section 4 of issues outlined in the RMP Evaluation Report (Round ‘Reconciliation 1)’). The RMP evaluator agrees with the clinical evaluator that patients with risk factors for cardiac disease could be more sensitive to the effects of an increased dose of avanafil. The sponsor should add interval prolongation’ as a potential risk to the ASA and ‘QT undertake to give specific consideration to arrhythmia events in the PSURs. In the EU-RMP, the sponsor acknowledges the possibility of recreational use and misuse of PDE5 inhibitors, including the use of PDE5 inhibitor with other illicit drugs including ketamine and amyl nitrate which may lead to serious hypotension. The evaluator has noted that concomitant use of avanafil and nitrates is listed under This ‘Contraindication’. routine risk minimisation measure is considered adequate. The sponsor should undertake to report all the serious adverse events related to recreational use and off-label use in the PSURs. Advice from the Advisory Committee on the Safety of Medicines (ACSOM) ACSOM advice was not sought for this submission.
evaluations performed in this study. In regard to the proposed routine risk minimisation activities, it is recommended to the Delegate that the PI be updated to include the following statement ‘Use in the elderly’ as men >70 years remains missing information: ‘Data on patients older than 70 years are limited’. (As in the EU SmPC) The sponsor notes the comment. Any proposed changes will be made to the PI after the Delegates overview. The evaluator has noted the sponsor’s response. The recommendation on the PI document remains, for consideration by the Delegate. Summary of recommendations It is considered that the sponsor’s response to the TGA has adequately addressed most of the issues identified in the RMP evaluation report. Additional recommendations are detailed below. Outstanding issues Issues in relation to the RMP The recommendation on the draft Product Information remains, awaiting consideration by the Delegate. Additional recommendations The evaluator supports the clinical evaluator’s comments. The sponsor has provided a justification as to why QT interval prolongation is not considered a safety concern for avanafil (see sponsor’s response to Recommendation 4 under section 4 ‘Reconciliation of issues outlined in the RMP Evaluation Report (Round 1)’). The RMP evaluator agrees with the clinical evaluator that patients with risk factors for cardiac disease could be more sensitive to the effects of an increased dose of avanafil. The sponsor should add ‘QT interval prolongation’ as a potential risk to the ASA and undertake to give specific consideration to arrhythmia events in the PSURs. In the EU-RMP, the sponsor acknowledges the possibility of recreational use and misuse of PDE5 inhibitors, including the use of PDE5 inhibitor with other illicit drugs including ketamine and amyl nitrate which may lead to serious hypotension. The evaluator has noted that concomitant use of avanafil and nitrates is listed under ‘Contraindication’. This routine risk minimisation measure is considered adequate. The sponsor should undertake to report all the serious adverse events related to recreational use and off-label use in the PSURs. Advice from the Advisory Committee on the Safety of Medicines (ACSOM) ACSOM advice was not sought for this submission.
auspar-avanafil-161027.docx