RMP An acceptable RMP has been provided along with acceptable assurances from the sponsor to address outstanding matters. Overall The Delegate considers the efficacy and safety of golimumab at the dose requested to be satisfactorily established for the new indication of non-radiographic axial spondyloarthritis pending further advice from ACPM and the PI changes requested herein. Data deficiencies The size and duration of exposure to golimumab is limited. is a lack of data on disease modifying effects, for example structural changes. The pivotal study only included patients aged 18 to 45 years. Conditions of registration The following are proposed as conditions of registration and the sponsor is invited to comment on this in the Pre-ACPM response: The implementation in Australia of the EU Risk Management Plan for Simponi (golimumab), version 15.0 2 February 2016, DLP 6 October 2015), with the Australian Specific Annex, version 4.1 (dated 29 March 2016), included with submission PM-2015-01879-1-3, and the sponsor’s response to the RMP dated 28 May 2016 and the responses in the Pre-ACPM Response dated [date], and any subsequent revisions, as agreed with the TGA. Questions for the sponsor The sponsor is requested to address the following issues in the Pre-ACPM Response: What further data/studies are planned or ongoing in nr-Axial- SpA for golimumab? Are any of these studies expected to assess the effects of golimumab on long term disability or radiographic progression (structural change)? Delegate’s considerations The primary issues with this submission are as follows with further information in the Discussion section: is some uncertainty whether AS and nr-Axial SpA represent distinct but overlapping disorders or simply different points in the severity or chronology of illness along a single spectrum. Patients may also spontaneously remit. The pivotal study only included patients aged 18 to 45 years. The sponsor has been requested to include a statement regarding suitable treatment duration before continued therapy should be reconsidered in patients not responding. Delegate’s proposed action The Delegate had no reason to say, at this time, that the application for Simponi should not be approved for registration, pending further advice from ACPM. The Delegate’s suggested wording for the indications is: Non-radiographic spondyloarthritis (nr-Axial SpA)
RMP An acceptable RMP has been provided along with acceptable assurances from the sponsor to address outstanding matters. Overall The Delegate considers the efficacy and safety of golimumab at the dose requested to be satisfactorily established for the new indication of non-radiographic axial spondyloarthritis pending further advice from ACPM and the PI changes requested herein. Data deficiencies The size and duration of exposure to golimumab is limited. is a lack of data on disease modifying effects, for example structural changes. The pivotal study only included patients aged 18 to 45 years. Conditions of registration The following are proposed as conditions of registration and the sponsor is invited to comment on this in the Pre-ACPM response: The implementation in Australia of the EU Risk Management Plan for Simponi (golimumab), version 15.0 2 February 2016, DLP 6 October 2015), with the Australian Specific Annex, version 4.1 (dated 29 March 2016), included with submission PM-2015-01879-1-3, and the sponsor’s response to the RMP dated 28 May 2016 and the responses in the Pre-ACPM Response dated [date], and any subsequent revisions, as agreed with the TGA. Questions for the sponsor The sponsor is requested to address the following issues in the Pre-ACPM Response: What further data/studies are planned or ongoing in nr-Axial- SpA for golimumab? Are any of these studies expected to assess the effects of golimumab on long term disability or radiographic progression (structural change)? Delegate’s considerations The primary issues with this submission are as follows with further information in the Discussion section: is some uncertainty whether AS and nr-Axial SpA represent distinct but overlapping disorders or simply different points in the severity or chronology of illness along a single spectrum. Patients may also spontaneously remit. The pivotal study only included patients aged 18 to 45 years. The sponsor has been requested to include a statement regarding suitable treatment duration before continued therapy should be reconsidered in patients not responding. Delegate’s proposed action The Delegate had no reason to say, at this time, that the application for Simponi should not be approved for registration, pending further advice from ACPM. The Delegate’s suggested wording for the indications is: Non-radiographic spondyloarthritis (nr-Axial SpA)